phase iii clinical trials

Summary

Summary: Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.

Top Publications

  1. ncbi [Second-line treatment for advanced non-small-cell lung cancers]
    Hirotoshi Akita
    Dept of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo 060 8638, Japan
    Gan To Kagaku Ryoho 32:15-8. 2005
  2. ncbi Lessons from phase III clinical trials on anti-VEGF therapy for cancer
    Rakesh K Jain
    Department of Radiation Oncology, Harvard Medical School, and Massachusetts General Hospital, Boston, MA 02114, USA
    Nat Clin Pract Oncol 3:24-40. 2006
  3. ncbi Capecitabine as first-line treatment in colorectal cancer. Pooled data from two large, phase III trials
    C Twelves
    Alexander Stone Building, CRC Department of Medical Oncology, Switchback Road, Garscube Estate, Bearsden, Glasgow G61 1BD, UK
    Eur J Cancer 38:15-20. 2002
  4. pmc Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis
    William L Macias
    Lilly Research Laboratories, Indianapolis, Indiana, USA
    Crit Care 9:R607-22. 2005
  5. ncbi Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B
    David M Dilts
    Center for Management Research in Healthcare, Vanderbilt University, Nashville, TN, USA
    J Clin Oncol 24:4553-7. 2006
  6. ncbi Sequential designs for phase III clinical trials incorporating treatment selection
    Nigel Stallard
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P O Box 240, Earley Gate, Reading, Berkshire RG6 6FN, UK
    Stat Med 22:689-703. 2003
  7. ncbi Current evidence from phase III clinical trials of selenium supplementation in critically Ill patients: why should we bother?
    S Peter Stawicki
    Department of Surgery, Division of Traumatology and Surgical Critical Care, University of Pennsylvania School of Medicine, 2 Dulles, Trauma Center at Penn, Philadelphia, PA 19104, USA
    Mini Rev Med Chem 7:693-9. 2007
  8. ncbi Development of StaphVAX, a polysaccharide conjugate vaccine against S. aureus infection: from the lab bench to phase III clinical trials
    Ali I Fattom
    Nabi Biopharmaceuticals, 12280 Wilkins Avenue, Rockville, MD 20852, USA
    Vaccine 22:880-7. 2004
  9. ncbi Radiotherapy and oral capecitabine in the preoperative treatment of patients with rectal cancer: rationale, preliminary results and perspectives
    Renzo Corvò
    National Institute for Cancer Research, Genoa, Italy
    Tumori 89:361-7. 2003
  10. ncbi Innovative strategies in lymphoma therapy
    Ulrich Jager
    Division of Hematology and Hemostaseology, Department of Internal Medicine I, University of Vienna, Vienna, Austria
    Wien Klin Wochenschr 115:462-70. 2003

Detail Information

Publications247 found, 100 shown here

  1. ncbi [Second-line treatment for advanced non-small-cell lung cancers]
    Hirotoshi Akita
    Dept of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo 060 8638, Japan
    Gan To Kagaku Ryoho 32:15-8. 2005
    ..Symptom relief, improvement of QOL, and minimum toxicity as well as survival benefit have to be evaluated in phase III trials in order to develop a new second-line chemotherapy...
  2. ncbi Lessons from phase III clinical trials on anti-VEGF therapy for cancer
    Rakesh K Jain
    Department of Radiation Oncology, Harvard Medical School, and Massachusetts General Hospital, Boston, MA 02114, USA
    Nat Clin Pract Oncol 3:24-40. 2006
    ..We summarize three of the many potential mechanisms of action of anti-VEGF agents, and also discuss progress relating to the identification of potential biomarkers for anti-VEGF-agent efficacy in humans...
  3. ncbi Capecitabine as first-line treatment in colorectal cancer. Pooled data from two large, phase III trials
    C Twelves
    Alexander Stone Building, CRC Department of Medical Oncology, Switchback Road, Garscube Estate, Bearsden, Glasgow G61 1BD, UK
    Eur J Cancer 38:15-20. 2002
    ..001) of diarrhoea, stomatitis, nausea and alopecia, together with a reduced treatment-related hospitalisation rate. In addition, the incidence of neutropenic fever/sepsis was significantly lower in patients receiving capecitabine...
  4. pmc Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis
    William L Macias
    Lilly Research Laboratories, Indianapolis, Indiana, USA
    Crit Care 9:R607-22. 2005
    ..Such an interaction might warrant a change in the assumptions that underlie current trial designs...
  5. ncbi Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B
    David M Dilts
    Center for Management Research in Healthcare, Vanderbilt University, Nashville, TN, USA
    J Clin Oncol 24:4553-7. 2006
    National Cancer Institute-sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied...
  6. ncbi Sequential designs for phase III clinical trials incorporating treatment selection
    Nigel Stallard
    Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P O Box 240, Earley Gate, Reading, Berkshire RG6 6FN, UK
    Stat Med 22:689-703. 2003
    Most statistical methodology for phase III clinical trials focuses on the comparison of a single experimental treatment with a control...
  7. ncbi Current evidence from phase III clinical trials of selenium supplementation in critically Ill patients: why should we bother?
    S Peter Stawicki
    Department of Surgery, Division of Traumatology and Surgical Critical Care, University of Pennsylvania School of Medicine, 2 Dulles, Trauma Center at Penn, Philadelphia, PA 19104, USA
    Mini Rev Med Chem 7:693-9. 2007
    ..Further research in the setting of well-designed, prospective, randomized trials is necessary to better define the role of selenium supplementation in critically ill patients...
  8. ncbi Development of StaphVAX, a polysaccharide conjugate vaccine against S. aureus infection: from the lab bench to phase III clinical trials
    Ali I Fattom
    Nabi Biopharmaceuticals, 12280 Wilkins Avenue, Rockville, MD 20852, USA
    Vaccine 22:880-7. 2004
    ..aureus bacteremia for up to 10 months following a single immunization. The history, epidemiology, serology, and development of StaphVAX, including preclinical and clinical studies demonstrating efficacy are described in this review...
  9. ncbi Radiotherapy and oral capecitabine in the preoperative treatment of patients with rectal cancer: rationale, preliminary results and perspectives
    Renzo Corvò
    National Institute for Cancer Research, Genoa, Italy
    Tumori 89:361-7. 2003
    ..It is likely that these new chemoradiation associations might increase rectal cancer clearance, hopefully without increasing toxicity...
  10. ncbi Innovative strategies in lymphoma therapy
    Ulrich Jager
    Division of Hematology and Hemostaseology, Department of Internal Medicine I, University of Vienna, Vienna, Austria
    Wien Klin Wochenschr 115:462-70. 2003
    ..These exciting new strategies will improve the success rate in aggressive NHLs and may even challenge the paradigm of incurability of indolent lymphomas...
  11. ncbi The global role of irinotecan in the treatment of lung cancer: 2003 update
    Corey J Langer
    Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA
    Oncology (Williston Park) 17:30-40. 2003
    ..It is hoped that data from these and other studies will help investigators to more clearly delineate a role for irinotecan in the management of lung cancer...
  12. ncbi Axokine (Regeneron)
    Antonio Preti
    Genneruxi Medical Center, via Costantinopoli 42, I 09129 Cagliari, Italy
    IDrugs 6:696-701. 2003
    ..Axokine, a second-generation neurotrophic factor that is related to ciliary neurotrophic factor (CNTF), is under development by Regeneron for the potential treatment of obesity and associated complications such as type 2 diabetes...
  13. ncbi Lanthanum carbonate (Shire)
    Francesco Locatelli
    A Manzoni Hospital, Department of Nephrology and Dialysis, Via Dell Eremo 9 11, 23900 Lecco LC, Italy
    IDrugs 6:688-95. 2003
    ..It is currently in pre-registration in the US, Canada and Western Europe, and earlier stage clinical trials are ongoing in Japan...
  14. ncbi Ferucarbotran (Resovist): a new clinically approved RES-specific contrast agent for contrast-enhanced MRI of the liver: properties, clinical development, and applications
    Peter Reimer
    Department of Radiology, Stadtisches Klinikum Karlsruhe, Moltkestrasse 90, 76133 Karlsruhe, Germany
    Eur Radiol 13:1266-76. 2003
    ....
  15. ncbi Gemcitabine and paclitaxel in metastatic breast cancer: a review
    Ramon Colomer
    Medical Oncology Division, Institut Catala d Oncologia, Girona, Spain
    Oncology (Williston Park) 18:8-12. 2004
    ..Triplet combinations, in which an anthracycline is added to gemcitabine/paclitaxel, are being explored in the metastatic and neoadjuvant settings...
  16. ncbi Radiochemotherapy of malignant glioma in adults. Clinical experiences
    Rolf Dieter Kortmann
    Department for Radiation Oncology, University of Tubingen, Germany
    Strahlenther Onkol 179:219-32. 2003
    ..Standard treatment in patients with malignant glioma consists of surgery and postoperative radiotherapy. A high early recurrence rate, particularly in glioblastoma, has led to the investigation of additional chemotherapy...
  17. ncbi Rationale and design of the enoximone clinical trials program
    Brian D Lowes
    University of Colorado Health Sciences Center, Denver, Colorado 80262, USA
    J Card Fail 11:659-69. 2005
    ..Based on these data, the ability of enoximone to deliver safe and efficacious palliative treatment of advanced/ultra-advanced chronic heart failure is being evaluated in Phase III clinical trials.
  18. ncbi A systematic review of the relation between interleukin-2 schedule and outcome in patients with metastatic renal cell cancer
    G Baaten
    Faculty of Medicine, University of Maastricht, Maastricht, The Netherlands
    Eur J Cancer 40:1127-44. 2004
    ..These data emphasize the importance of randomized clinical trials in determining what should be regarded as optimum therapy...
  19. ncbi High-dose chemotherapy for breast cancer: the French PEGASE experience
    Henri Roche
    Institut Claudius Regaud, 31052 Toulouse Cedex, France
    Cancer Control 10:42-7. 2003
    ..The French PEGASE Group was founded to perform larger and properly randomized comparative studies of this approach...
  20. ncbi Clinical trial designs for targeted agents
    Brigette B Y Ma
    Department of Medical Oncology, Princess Margaret Hospital, University Health Network, 610 University Avenue, Toronto, ON M5G 2M9, Canada
    Hematol Oncol Clin North Am 16:1287-305. 2002
    ....
  21. ncbi Darbepoetin alfa: in patients with chemotherapy-related anaemia
    Risto S Cvetkovic
    Adis International Limited, Mairangi Bay, Auckland, New Zealand
    Drugs 63:1067-74; discussion 1075-7. 2003
    ..019 vs placebo]. black triangle Darbepoetin alfa was generally well tolerated in clinical trials. The most frequent darbepoetin alfa-related adverse events were: body oedema, arthralgia and skin rash...
  22. ncbi Clinical experience with the HER1/EGFR tyrosine kinase inhibitor erlotinib
    Alan Sandler
    Division of Hematology Oncology, Vanderbilt University, Medical Center, Nashville, Tennessee, USA
    Oncology (Williston Park) 17:17-22. 2003
    ..The phase III BR.21 trial is assessing erlotinib monotherapy in advanced refractory non-small-cell lung cancer. Results of these phase II trials will soon be available...
  23. ncbi Management of metastatic cutaneous melanoma
    Antonio C Buzaid
    Oncology Center, Hospital Sirio Libanes, Sao Paulo, Brazil
    Oncology (Williston Park) 18:1443-50; discussion 1457-9. 2004
    ....
  24. ncbi Dose-dense chemotherapy for aggressive non-Hodgkin lymphoma
    Lowell Anderson-Reitz
    Baylor Charles A Sammons Cancer Center, Dallas, TX 75246, USA
    Cancer Nurs 29:198-206. 2006
    ..Nurses can play a major role in the implementation of evidence-based supportive care strategies in clinical practice to ensure safe use of dose-dense chemotherapy regimens...
  25. ncbi Rapid development of S-1 in the west for therapy of advanced gastric carcinoma
    Jaffer A Ajani
    Department of Gastrointestinal Medical Oncology, The University of Texas M D Anderson Cancer Center, Houston, Texas, USA
    Gan To Kagaku Ryoho 33:117-20. 2006
    ..Phase I/II studies of the combination of S-1 plus cisplatin have been completed and a global phase III study, accruing rapidly, is comparing S-1 plus cisplatin to 5-fluorouracil plus cisplatin (a reference regimen)...
  26. ncbi [Combination therapy with S-1 plus docetaxel (DOC) for previously treated patients with non-small cell lung cancer]
    Shinji Atagi
    Dept of Internal Medicine, National Hospital Organization Kinki chuo Chest Medical Center, Osaka, Japan
    Gan To Kagaku Ryoho 33:197-201. 2006
    ..Partial response was achieved in 4 of the 9 patients. This combined chemotherapy consisting of S-1 and DOC may prove effective for treating recurrent cases of NSCLC. A phase II study is ongoing...
  27. ncbi New and emerging treatment of chronic hepatitis B
    Emmet B Keeffe
    Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA
    Clin Gastroenterol Hepatol 5:285-94. 2007
    ..In large phase III clinical trials, these agents have demonstrated superior efficacy over lamivudine in both HBeAg-positive and HBeAg-..
  28. ncbi [Lung cancer]
    Akira Ono
    Division of Thoracic Oncology, Shizuoka Cancer Center
    Gan To Kagaku Ryoho 34:367-73. 2007
    ..A phase III study of carboplatin+etoposide versus amrubicin under way. These studies should aim to optimize several agents for elderly patients and prolong survival, palliative care...
  29. ncbi [Hormone-refractory prostate cancer]
    I Alexandre
    Service d Oncologie Medicale, Groupe Hospitalier Pitie Salpetriere, Assistance Publique, Hopitaux de Paris, 41 87, Boulevard de l Hopital, 75013 Paris, France
    Ann Urol (Paris) 41:47-55. 2007
    ..Such recent advances constitute a real progress in the management of prostate cancer, namely the pharmacological combinations with a promising efficacy and little toxicity...
  30. ncbi Aprepitant for chemotherapy-induced nausea and vomiting
    Linda A Flemm
    Clin J Oncol Nurs 8:303-6. 2004
    ..Oncology nurses continue to play a key role in helping patients adhere to their antiemetic schedules, stressing the importance of prevention of nausea and vomiting...
  31. ncbi Palliative chemotherapy for advanced gastric cancer
    S S Wöhrer
    Department of Internal Medicine I, Division of Oncology, University of Vienna, Vienna, Austria
    Ann Oncol 15:1585-95. 2004
    ..The objective of this article is to review the clinical trials utilizing cytotoxic chemotherapy in patients with advanced gastric cancer...
  32. ncbi [Current strategies in the treatment of advanced stage mantle cell lymphoma]
    G Lenz
    Medizinische Klinik III, Klinikum der Ludwig Maximilians Universität, Munchen
    Dtsch Med Wochenschr 129:2429-33. 2004
    ..g. proteasome inhibitors or radiolabeled antibodies) are urgently warranted to further improve the long-term outcome of MCL...
  33. ncbi [Non-small cell lung cancer (NSCLC): the evolution of neo-adjuvant chemotherapy in the last 15 years]
    Antonio Santo
    Divisione Clinicizzata di Oncologia Medica, Ospedale Civile Maggiore, Verona
    Recenti Prog Med 97:211-8. 2006
    ..The aim of neo-adjuvant chemotherapy is to address early the distant micrometastasis and to allow, through a downstaging, surgical resection of tumor not suitable to surgery or partially respectable at diagnosis...
  34. ncbi [Radiation and concomitant chemotherapy after surgery for breast cancer]
    G Calais
    Clinique d Oncologie et Radiothérapie, Hopital Bretonneau, 2, boulevard Tonnelle, 37044 Tours, France
    Cancer Radiother 8:39-47. 2004
    ..A randomized phase III trials has been conducted to compare sequential treatment with chemotherapy first and radiation versus concomitant treatments. Preliminary results of this study are presented...
  35. ncbi Developmental chemotherapy and management of recurrent ovarian cancer
    Michael A Bookman
    Fox Chase Cancer Center, Philadelphia, PA 19111, USA
    J Clin Oncol 21:149s-167s. 2003
    ....
  36. ncbi [Therapy of malignant melanoma at the stage of distant metastasis]
    C Garbe
    Sektion Dermatologische Onkologie, Universitäts Hautklinik, Eberhard Karls Universitat, Tubingen
    Hautarzt 55:195-213. 2004
    ..Effective cancer vaccination strategies and blockade of melanoma specific target molecules are currently developed as new treatment options...
  37. ncbi Role of pegylated liposomal doxorubicin in ovarian cancer
    J Tate Thigpen
    Division of Oncology, Department of Medicine, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA
    Gynecol Oncol 96:10-8. 2005
    ..The plethora of agents currently available present difficult choices for physicians. The present effort seeks to examine the role of one of these agents, pegylated liposomal doxorubicin...
  38. ncbi Thalidomide in newly diagnosed multiple myeloma and overview of experience in smoldering/indolent disease
    S Vincent Rajkumar
    Division of Hematology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    Semin Hematol 40:17-22. 2003
    ..Phase III trials of thalidomide in newly diagnosed symptomatic multiple myeloma or smoldering/indolent disease are ongoing...
  39. ncbi Epidermal growth factor receptor expression correlates with poor survival in patients who have breast carcinoma treated with doxorubicin-based neoadjuvant chemotherapy
    Thomas A Buchholz
    Department of Radiation Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX 77030, USA
    Cancer 104:676-81. 2005
    ..To the authors' knowledge there are few data that correlate the expression of the epidermal growth factor receptor (EGFR) with the outcome of patients who have breast carcinoma and are treated with anthracycline chemotherapy...
  40. ncbi Correlation of p53 immunostaining in primary and residual ovarian cancer at the time of positive second-look laparotomy and its prognostic role: a Southwest Oncology Group ancillary study
    Debra Hawes
    University of Southern California, Los Angeles, CA 90033, USA
    Gynecol Oncol 87:17-23. 2002
    ....
  41. ncbi Gemcitabine/carboplatin in advanced non-small cell lung cancer
    Petr Zatloukal
    Department of Pneumology and Thoracic Surgery, Third Medical Faculty of Charles University, Postgraduate Medical School and Faculty, Hospital Na Bulovce, Budinova 2, Prague 180 81, Czech Republic
    Lung Cancer 38:S33-6. 2002
    ..A better understanding of the relative toxicities of these regimens should be provided by the final results of this trial...
  42. ncbi Radioimmunotherapy with yttrium-90 ibritumomab tiuxetan for patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma
    Thierry Alcindor
    Department of Internal Medicine, Division of Hematology, Mayo Clinic and Mayo Foundation, 200 First Street, Rochester, MN 55905, USA
    Curr Treat Options Oncol 3:275-82. 2002
    ..The outcome of these studies will be helpful in deciding how best to integrate this new modality into the treatment paradigm of NHL...
  43. ncbi Induction therapy before surgery for non-small cell lung cancer
    Roberta Ferraldeschi
    Dipartimento di Medicina Sperimentale, Universita La Sapienza, Roma, Italy
    Rays 29:445-52. 2004
    ..The ongoing randomized trials will probably provide more reliable indications to define the management of the large number of patients with locally advanced disease...
  44. ncbi Concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer
    Everett E Vokes
    Section of Hematology Oncology, Department of Medicine, University of Chicago, 5841 S Maryland Avenue, Chicago, IL 60637 1470, USA
    Clin Cancer Res 11:5045s-5050s. 2005
    ..Currently ongoing trials involving novel approaches are reviewed here...
  45. ncbi [Proteasome inhibitors]
    J Alexandre
    Service de Medecine Interne, Unité d Oncologie Médicale, Groupe Hospitalier Cochin Saint Vincent De Paul, 27, rue du Faubourg Saint Jacques, 75014 Paris, France
    Rev Med Interne 26:812-5. 2005
    ..Proteasome is involved in cell cycle and apoptosis regulation. Its deregulation could participate to oncogenesis...
  46. ncbi Bladder cancer clinical trials
    Seth P Lerner
    Scott Department of Urology, Baylor College of Medicine, Houston, TX 77030, USA
    Urol Oncol 23:275-9. 2005
    ..The present article reviews this important area of clinical trials research...
  47. ncbi Pathological complete response following pre-operative chemoradiotherapy in rectal cancer: analysis of phase II/III trials
    A Hartley
    Cancer Centre, Queen Elizabeth Hospital, Birmingham, UK
    Br J Radiol 78:934-8. 2005
    ..Important factors not considered in this analysis include the variability in pathological examination and in the time interval between CRT and surgery. In addition, the toxicity of the CRT regimens requires further investigation...
  48. ncbi Fulvestrant (AstraZeneca)
    Stephen R D Johnston
    Department of Medicine, Royal Marsden Hospital and Institute of Cancer Research, London, UK
    Curr Opin Investig Drugs 3:305-12. 2002
    ..Analysts at Lehman Brothers predicted in December 2001, that the product has a 90% chance of making it to market in 2002, with peak sales potential in this year of $800 million [434768]...
  49. ncbi The outcome of advanced or recurrent non-squamous carcinoma of the uterine cervix after platinum-based combination chemotherapy
    E Kastritis
    Department of Clinical Therapeutics, Alexandra Hospital, Athens University School of Medicine, 31 Komninon Street, Haidari, 124 62 Athens, Greece
    Gynecol Oncol 99:376-82. 2005
    ..We compared the outcome of patients with non-squamous with that of squamous cell carcinomas after platinum-based combination chemotherapy as first line therapy for stage IV or recurrent cervical carcinoma...
  50. ncbi Iseganan (IntraBiotics pharmaceuticals)
    Jeffrey H Toney
    Merck Research Laboratories, Rahway, NJ 07065 0900, USA
    Curr Opin Investig Drugs 3:225-8. 2002
    ..In May 2000, analysts at SG Cowen predicted the drug's potential market at US $100 to US $200 million [376325]...
  51. ncbi Perspectives on salvage therapy for non-small-cell lung cancer
    Federico Cappuzzo
    Division of Medical Oncology, Department of Oncology, Bellaria Hospital, Bologna, Italy
    Oncology (Williston Park) 19:989-95; discussion 995-6, 999, 1003-4, passim. 2005
    ..Both drugs have been approved for the treatment of pretreated NSCLC. Other drugs, such as cetuximab (Erbitux) and bevacizumab (Avastin) have shown promising activity in NSCLC and are currently being tested in clinical trials...
  52. ncbi Prospective clinical trials of biotherapies in solid tumors: a 5-year survey
    Alessandro Ottaiano
    Department of Medical Oncology, ULSS2, Santa Maria del Prato Hospital, via Bagnols Ceze, Feltre BL, Italy
    Cancer Immunol Immunother 54:44-50. 2005
    ..To review the content and quality of prospective clinical trials of biotherapies in solid tumors...
  53. ncbi [Therapy of hormone refractory prostate cancer: new standards, new trends]
    C Wulfing
    Klinik und Poliklinik fur Urologie, Universitatsklinikum Munster
    Aktuelle Urol 36:342-8. 2005
    ....
  54. ncbi A comprehensive update on the use of chemotherapy for metastatic pancreatic adenocarcinoma
    Peter Kozuch
    Department of Medical Oncology, St Luke s Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, 425 West 59th Street, Suite 1A, New York, NY 10019, USA
    Hematol Oncol Clin North Am 16:123-38. 2002
    ..Further investigation is needed to determine optimal incorporation of so-called targeted therapy with combination chemotherapy...
  55. ncbi Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens
    Mohammad I Zia
    Department of Medical Oncology and Hematology, Princess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada
    J Clin Oncol 23:6982-91. 2005
    ..To determine whether promising results from phase II studies could be reproduced in phase III studies, and to examine which characteristics of phase II studies might be of predictive value for subsequent phase III studies...
  56. ncbi Pexelizumab Alexion
    Per A Whiss
    Faculty of Health Sciences, Department of Medicine and Care, Linköping Universitet, Sweden
    Curr Opin Investig Drugs 3:870-7. 2002
    ..In the rest of the world, CPB approvals were expected to begin in the second half of 2005. Sales in 2006 were expected to reach US $35 million, rising to US $110 million in 2008 [438051]...
  57. ncbi Role of pegylated liposomal doxorubicin (PLD) in epithelial ovarian cancer
    D Lorusso
    Department of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy
    J Chemother 16:98-103. 2004
    ..Pegylated liposomal doxorubicin is effective as a second line treatment in ovarian cancer patients; comparative data are needed to establish its role in first line therapy...
  58. ncbi Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer
    Alexandru Eniu
    Cancer Institute, Ion Chiricuta Cluj Napoca, Romania
    Oncologist 10:665-85. 2005
    ..Weekly docetaxel and paclitaxel regimens represent valuable therapeutic options for women with metastatic breast cancer and have entered evaluation as part of adjuvant therapy for this disease...
  59. ncbi Eptifibatide in percutaneous coronary intervention. A review
    J P Dery
    Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA
    Minerva Cardioangiol 50:531-46. 2002
    ..These landmark studies, which are the focus of this review, emphasize the importance of considering the use of GP IIb-IIIa inhibitors in all patients undergoing PCI...
  60. ncbi Pemetrexed in malignant pleural mesothelioma
    Maitreyee Hazarika
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Clin Cancer Res 11:982-92. 2005
    ..Indianapolis, IN) by the U.S. Food and Drug Administration (FDA) of a New Drug Application for the treatment of malignant pleural mesothelioma (MPM)...
  61. ncbi Docetaxel in combination with platinums (cisplatin or carboplatin) in advanced and metastatic non-small cell lung cancer
    Chandra P Belani
    Lung and Thoracic Cancer Program, University of Pittsburgh Cancer Institute, PA
    Semin Oncol 29:4-9. 2002
    ....
  62. ncbi Gemcitabine (Gemzar)-based induction chemotherapy in non-small-cell lung cancer
    Giorgio Vittorio Scagliotti
    Thoracic Oncology Unit, Department of Clinical and Biological Sciences, S Luigi Hospital, University of Torino, Orbassano, Turin, Italy
    Lung Cancer 38:S13-9. 2002
    ....
  63. ncbi Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature
    Giannicola D'Addario
    Kantonsspital St Gallen, Departement Innere Medizin, Fachbereich Onkologie Haematologie, Rorschacherstrasse 95, 9007 St Gallen, Switzerland
    J Clin Oncol 23:2926-36. 2005
    ..This meta-analysis was performed to compare the activity, efficacy and toxicity of platinum-based versus non-platinum-based chemotherapy in patients with advanced non-small-cell lung cancer...
  64. ncbi Fludarabine combination therapy for the treatment of chronic lymphocytic leukemia
    Barbara Schmitt
    Klinikum der Ludwig Maximilians Universität, Munich, Germany
    Clin Lymphoma 3:26-35. 2002
    ..It remains to be shown whether patients with CLL achieve improved overall survival with these combination chemotherapies...
  65. ncbi Topoisomerase I-based nonplatinum combinations in non-small-cell lung cancer
    Caio Max S Rocha Lima
    H Lee Moffitt Cancer Center, GI Program Office, Tampa, Florida 33612, USA
    Oncology (Williston Park) 16:25-31. 2002
    ..This article reviews the topoisomerase I-inhibitor nonplatinum combinations in the management of advanced non-small-cell lung cancer...
  66. ncbi Clinical development of microbicides for the prevention of HIV infection
    OSMOND J D'CRUZ
    Drug Discovery Program, Parker Hughes Institute 2657 Patton Road, St Paul, Minnesota 55113, USA
    Curr Pharm Des 10:315-36. 2004
    ..The currently marketed detergent-type spermicide, nonoxynol-9 (N-9), has failed in Phase III clinical trials, due to the drug-induced formation of localized genital lesions that might in fact actually promote ..
  67. ncbi Anti-interleukin-2 receptor antibodies for the prevention of rejection in pediatric renal transplant patients: current status
    Agnieszka Swiatecka-Urban
    Department of Physiology, Dartmouth Medical School, Hanover, New Hampshire 03755, USA
    Paediatr Drugs 5:699-716. 2003
    ..In placebo-controlled phase III clinical trials in adults, daclizumab and basiliximab in combination with calcineurin inhibitor-based immunosuppression, ..
  68. ncbi Savings in the cost of caring for patients with Alzheimer's disease in Canada: an analysis of treatment with rivastigmine
    A B Hauber
    Research Triangle Institute, Center for Economics Research, Research Triangle Park, North Carolina 27709 2194, USA
    Clin Ther 22:439-51. 2000
    ..To estimate per-patient potential cost savings using rivastigmine in the treatment of Alzheimer's disease (AD) in Canada...
  69. ncbi Pharmacokinetics and tolerability of extended-release clarithromycin
    D R Guay
    Institute for the Study of Geriatric Pharmacotherapy, College of Pharmacy, University of Minnesota, Minneapolis 55455, USA
    Clin Ther 23:566-77. 2001
    ..It is indicated for the treatment of a wide variety of respiratory and dermatologic infections in children and adults as well as prophylaxis and treatment of Mycobacterium avium complex infection and peptic ulcers due to H. pylori...
  70. ncbi Pathologically-activated therapeutics for neuroprotection: mechanism of NMDA receptor block by memantine and S-nitrosylation
    Stuart A Lipton
    The Burnham Institute for Medical Research, The Salk Institute for Biological Studies, The Scripps Research Institute, and the University of California San Diego, La Jolla, California 92037, USA
    Curr Drug Targets 8:621-32. 2007
    ..These second-generation drugs take advantage of the fact that the NMDA receptor has other modulatory sites in addition to its ion channel that potentially could also be used for safe but effective clinical intervention...
  71. ncbi The oral NK(1) antagonist, aprepitant, given with standard antiemetics provides protection against nausea and vomiting over multiple cycles of cisplatin-based chemotherapy: a combined analysis of two randomised, placebo-controlled phase III clinical trial
    R de Wit
    Rotterdam Cancer Institute and Erasmus University Medical Center, PO Box 5201, 3008, Rotterdam, The Netherlands
    Eur J Cancer 40:403-10. 2004
    ..than one cycle of chemotherapy, we examined combined data from the multiple cycles extensions of two phase III clinical trials of oral aprepitant plus standard therapy for the prevention of chemotherapy-induced nausea and vomiting...
  72. ncbi In vitro antifungal activities of anidulafungin and micafungin, licensed agents and the investigational triazole posaconazole as determined by NCCLS methods for 12,052 fungal isolates: review of the literature
    Ana Espinel-Ingroff
    Division of Infectious Diseases, VCU Medical Center, P O Box 49, Richmond, Virginia 23298 0049, USA
    Rev Iberoam Micol 20:121-36. 2003
    The echinocandins anidulafungin and micafungin and the triazole posaconazole are currently undergoing phase III clinical trials. Caspofungin and voriconazole have recently been licensed for the treatment of aspergillosis (both agents), ..
  73. ncbi Edoxaban: a new oral direct factor xa inhibitor
    A John Camm
    Division of Clinical Sciences, St Georges University of London, UK
    Drugs 71:1503-26. 2011
    Edoxaban is an oral direct factor Xa inhibitor that is currently undergoing investigation in phase III clinical trials for the prevention of stroke in patients with atrial fibrillation (AF) and for the prevention and treatment of venous ..
  74. ncbi Thrombotic thrombocytopenic purpura associated with ticlopidine in the setting of coronary artery stents and stroke prevention
    C L Bennett
    Institute for Health Services Research and Policy Studies, Robert H Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Ill, USA
    Arch Intern Med 159:2524-8. 1999
    ..Recently, Hoffman-LaRoche Pharmaceuticals, following reports of 20 deaths from ticlopidine-associated TTP, updated the information about the hematologic adverse effects of the drug...
  75. ncbi Rotavirus live, oral, pentavalent vaccine
    Catherine Tom-Revzon
    Department of Pharmacy Practice, Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA
    Clin Ther 29:2724-37. 2007
    ....
  76. pmc Efficacy of daptomycin in experimental endocarditis due to methicillin-resistant Staphylococcus aureus
    George Sakoulas
    Department of Medicine, Beth Israel Deaconess Medical Center Harvard Medical School, Boston, Massachusetts 02215, USA
    Antimicrob Agents Chemother 47:1714-8. 2003
    ..Daptomycin, a lipopeptide antibiotic now in phase III clinical trials, is rapidly bactericidal in vitro against a range of gram-positive organisms, including methicillin-..
  77. ncbi Thrombotic thrombocytopenic purpura associated with clopidogrel
    C L Bennett
    Veterans Affairs Chicago Healthcare System, Department of Medicine, The Robert H Lurie Comprehensive Cancer Center, Northwestern University, IL 60611, USA
    N Engl J Med 342:1773-7. 2000
    ..More than 3 million patients have received clopidogrel. We report the clinical and laboratory findings in 11 patients in whom thrombotic thrombocytopenic purpura developed during or soon after treatment with clopidogrel...
  78. ncbi Ustekinumab: treatment of adult moderate-to-severe chronic plaque psoriasis
    James V Scanlon
    School of Pharmacy, Biogen Idec Massachusetts College of Pharmacy and Health Sciences, Worcester Manchester, MA 01608, USA
    Ann Pharmacother 43:1456-65. 2009
    ..To systematically review the pharmacology, pharmacokinetics, clinical efficacy, and safety profile of ustekinumab to inform pharmacists and other healthcare professionals of this new biologic therapy for psoriasis...
  79. ncbi Ligands for mapping alphavbeta3-integrin expression in vivo
    Margret Schottelius
    Nuklearmedizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universitat Munchen, 81675 Munchen, Germany
    Acc Chem Res 42:969-80. 2009
    ..in cyclo(RGDf(NMe)V) (cilengitide), which is a drug for the treatment of glioblastoma (currently in phase III clinical trials)...
  80. ncbi Cinacalcet HCl: a novel treatment for secondary hyperparathyroidism caused by chronic kidney disease
    Pablo Urena Torres
    Service de néphrologie et dialyse, Clinique de l Orangerie, Aubervilliers, France
    J Ren Nutr 16:253-8. 2006
    ..cinacalcet HCl in treating SHPT in dialysis patients (n = 1,136) was studied in three similarly designed phase III clinical trials comparing patients receiving standard SHPT therapy plus cinacalcet HCl or plus placebo...
  81. pmc Characterization and sequence analysis of extended-spectrum-{beta}-lactamase-encoding genes from Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis isolates collected during tigecycline phase 3 clinical trials
    C Hal Jones
    Wyeth Research, Pearl River, New York 10965, USA
    Antimicrob Agents Chemother 53:465-75. 2009
    ..coli and K. pneumoniae isolates were tigecycline susceptible (MIC(90) = 2 microg/ml), warranting further studies to define the therapeutic utility of tigecycline against strains producing ESBLs in a clinical setting...
  82. pmc The mitochondrion is a site of trypanocidal action of the aromatic diamidine DB75 in bloodstream forms of Trypanosoma brucei
    Charlotte A Lanteri
    Department of Pathology and Laboratory Medicine, University of North Carolina, 2102C McGavran Greenberg Hall, Chapel Hill, NC 27599, USA
    Antimicrob Agents Chemother 52:875-82. 2008
    ..b. rhodesiense. An oral prodrug, DB289, is a promising new therapy undergoing phase III clinical trials for early-stage HAT...
  83. ncbi Should positive phase III clinical trial data be required before proton beam therapy is more widely adopted? No
    Herman Suit
    Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA
    Radiother Oncol 86:148-53. 2008
    Evaluate the rationale for the proposals that prior to a wider use of proton radiation therapy there must be supporting data from phase III clinical trials. That is, would less dose to normal tissues be an advantage to the patient?
  84. ncbi The molecular basis of memantine action in Alzheimer's disease and other neurologic disorders: low-affinity, uncompetitive antagonism
    Stuart A Lipton
    The Burnham Institute, The Salk Institute for Biological Studies, The Scripps Research Institute, and the University of California San Diego, La Jolla, California 92037, USA
    Curr Alzheimer Res 2:155-65. 2005
    ..These second-generation drugs take advantage of the fact that the NMDA receptor has other modulatory sites in addition to its ion channel that potentially could also be used for safe but effective clinical intervention...
  85. ncbi Paradigm shift in NMDA receptor antagonist drug development: molecular mechanism of uncompetitive inhibition by memantine in the treatment of Alzheimer's disease and other neurologic disorders
    Stuart A Lipton
    The Scripps Research Institute, and the University of California, San Diego, La Jolla, CA 92037, USA
    J Alzheimers Dis 6:S61-74. 2004
    ..These second-generation drugs take advantage of the fact that the NMDA receptor has other modulatory sites in addition to its ion channel that potentially could also be used for safe but effective clinical intervention...
  86. ncbi Differential biochemical and cellular actions of Premarin estrogens: distinct pharmacology of bazedoxifene-conjugated estrogens combination
    Thomas J Berrodin
    Nuclear Receptor Biology, Women s Health and Musculoskeletal Biology, Wyeth Research, 500 Arcola Road, Collegeville, Pennsylvania 19426, USA
    Mol Endocrinol 23:74-85. 2009
    ..CE) is under investigation to mitigate the estrogen/SERM side effects with promising results in Phase III clinical trials. To explore the mechanism of BZA/CE action, we investigated the recruitment of cofactor peptides to ..
  87. ncbi Tocilizumab: an interleukin-6 receptor inhibitor for the treatment of rheumatoid arthritis
    Susyn L Plushner
    Clinical Pharmacy Specialist in Rheumatology and Therapeutic Initiatives, 2045 Franklin St, Denver, CO 80205, USA
    Ann Pharmacother 42:1660-8. 2008
    ..To review the pharmacology, pharmacokinetics, clinical trial data, and safety profile of tocilizumab, a new biologic agent targeting the interleukin-6 cytokine receptor...
  88. ncbi Urogenital effects of selective estrogen receptor modulators: a systematic review
    P Albertazzi
    Centre for Metabolic Bone Disease, University of Hull, Hull, UK
    Climacteric 8:214-20. 2005
    ..The aim of this review was to systematically evaluate all the available data from randomized, controlled studies on the effects of these compounds on pelvic organ prolapse and urinary incontinence...
  89. ncbi Posaconazole as salvage therapy in a patient with disseminated zygomycosis: case report and review of the literature
    Robert Lee Page
    School of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado 80262, USA
    Pharmacotherapy 27:290-8. 2007
    ..Posaconazole is an orally available, extended-spectrum triazole antifungal being investigated in phase III clinical trials for the treatment and prevention of invasive fungal infections, including zygomycosis...
  90. pmc Occurrence of tetracycline resistance genes among Escherichia coli isolates from the phase 3 clinical trials for tigecycline
    Margareta Tuckman
    Infectious Diseases Discovery Research, Wyeth Research, Pearl River, New York 10965, USA
    Antimicrob Agents Chemother 51:3205-11. 2007
    ..5 microg/ml). The results provide a current (2002 to 2006) picture of the distribution of common tetracycline resistance determinants encoded in a globally sourced collection of clinical E. coli strains...
  91. ncbi Measuring social functioning with the personal and social performance scale in patients with acute symptoms of schizophrenia: interpretation of results of a pooled analysis of three Phase III trials of paliperidone extended-release tablets
    Donald L Patrick
    Department of Health Services and Seattle Quality of Life Group, University of Washington, Seattle, Washington, USA
    Clin Ther 32:275-92. 2010
    ..schizophrenia have been described in 3 randomized, double-blind, 6-week, placebo-controlled, fixed-dose, Phase III clinical trials. The validity and reliability of the Personal and Social Performance (PSP) scale, both in patients with ..
  92. ncbi Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor
    Camilo Rojas
    Research and Translational Development, MGI PHARMA INC, 6611 Tributary St, Baltimore, MD 21224 6515, USA
    Anesth Analg 107:469-78. 2008
    ..is a 5-HT(3)-receptor antagonist (5-HT(3)-RA) that has been shown to be superior to other 5-HT(3)-RAs in phase III clinical trials for the prevention of acute, delayed, and overall chemotherapy-induced nausea and vomiting...
  93. ncbi In vitro antifungal activities of voriconazole and reference agents as determined by NCCLS methods: review of the literature
    A Espinel-Ingroff
    Division of Infectious Diseases, Medical College of Virginia, Virginia Commonwealth University, Richmond 23298 0049, USA
    Mycopathologia 150:101-15. 2001
    Voriconazole (VfendTM) is a new triazole that currently is undergoing phase III clinical trials. This review summarizes the published data obtained by NCCLS methods on the in vitro antifungal activity of voriconazole in comparison to ..
  94. ncbi Biomarkers for assessment of pharmacologic activity for a vascular endothelial growth factor (VEGF) receptor inhibitor, PTK787/ZK 222584 (PTK/ZK): translation of biological activity in a mouse melanoma metastasis model to phase I studies in patients with
    Lucy Lee
    Translational and Clinical Development, Oncology Business Unit, Novartis Pharmaceutical, One Health Plaza Bldg 105, East Hanover, NJ 07936, USA
    Cancer Chemother Pharmacol 57:761-71. 2006
    ..targets all 3 vascular endothelial growth factor (VEGF) receptor tyrosine kinases and is currently in phase III clinical trials. In early clinical trials, PTK/ZK demonstrated a dose-dependent reduction in tumor vascular parameters ..
  95. ncbi Effectiveness and duration of daptomycin therapy in resolving clinical symptoms in the treatment of complicated skin and skin structure infections
    Jake E Krige
    University of Cape Town Health Sciences Faculty, Cape Town, South Africa
    Curr Med Res Opin 23:2147-56. 2007
    ..Compare the rapidity of the resolution of clinical signs and symptoms of complicated skin and skin structure infections (cSSSIs) caused by gram-positive organisms between daptomycin and comparator agents...
  96. ncbi A critical time for rotavirus vaccines: a review
    Nigel A Cunliffe
    Department of Medical Microbiology and Genitourinary Medicine, University of Liverpool, Royal Liverpool Children s Hospital, NHS Trust, UK
    Expert Rev Vaccines 4:521-32. 2005
    ..USA) have recently completed Phase III clinical trials, each involving more than 60,000 children...
  97. ncbi Anastrozole. A review of its use in the management of postmenopausal women with advanced breast cancer
    L R Wiseman
    Adis International Limited, Auckland, New Zealand
    Drugs Aging 13:321-32. 1998
    ..In two phase III clinical trials, anastrozole 1 or 10 mg/day showed similar clinical efficacy to that of oral megestrol (megestrol ..
  98. ncbi Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults
    Elliot V Hersh
    Oral and Maxillofacial Surgery and Pharmacology, School of Dental Medicine, University of Pennsylvania, 240 S 40th Street, Philadelphia, PA 19104, USA
    J Am Dent Assoc 139:1080-93. 2008
    The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia...
  99. ncbi Emerging lipid-lowering drugs: squalene synthase inhibitors
    Raghda K Elsayed
    University of Louisiana at Monroe, Department of Clinical and Administrative Sciences, College of Pharmacy, 700 University Avenue, Monroe, LA 71209, USA
    Expert Opin Emerg Drugs 13:309-22. 2008
    Lapaquistat was the only squalene synthase inhibitor in Phase III clinical trials in Europe and the United States, but was recently discontinued from clinical development...
  100. ncbi Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease
    H Fillit
    The Alzheimer s Drug Discovery Foundation, NY, NY, USA
    J Nutr Health Aging 14:640-7. 2010
    ..Incorporating pharmacoeconomic studies in phase III clinical trials for Alzheimer's disease presents a number of challenges...
  101. ncbi Do clinical grant payment practices in phase 3 clinical trials influence subsequent clinical investigator prescribing behavior?
    Harold E Glass
    TTC, LLC, Elkins Park, Pennsylvania 19027, USA
    Dis Manag 7:77-87. 2004
    ..Most significantly, investigators' post-study prescribing behavior was not related to RGA. Drug development and market forces explain the RGA, but RGA is not related to subsequent sponsor or study drug prescribing...

Research Grants78

  1. Alzheimer's Disease Therapeutic
    Trevor P Castor; Fiscal Year: 2012
    ..Later, Amylon plans to do an IPO to raise $100 million to conduct Phase III clinical trials and commercialize bryostatin 1 for Alzheimer's Disease and Cognitive Disorders...
  2. Novel Functions of S1P in Neuroinflammation
    TOMASZ K KORDULA; Fiscal Year: 2013
    ..FTY720-P) and after secretion targets four of the five S1P receptors, except S1P2, is currently in phase III clinical trials, and effectively reduces the frequency and severity of MS...
  3. Surgical Indirect Revascularization For Symptomatic Intracranial Aterial Stenosis
    Nestor Gonzalez; Fiscal Year: 2013
    ..This will require future phase III clinical trials. The present proposal has the purpose of testing in a phase II futility trial the potential of EDAS for ..
  4. Control of HIV drug resistance in older patients
    Alonso Heredia; Fiscal Year: 2010
    ..drug-resistant HIV viruses that use CCR5 as a coreceptor (the so-called R5 strains) and Vicriviroc is in Phase III clinical trials. Importantly, CCR5 antagonists, unlike HIV non-nucleoside reverse transcriptase and protease inhibitors, ..
  5. CHEMOPREVENTION OF SKIN CANCER PROGRAM PROJECT
    George Timothy Bowden; Fiscal Year: 2013
    ..While this PPG will not take on the task of delivery by running phase III clinical trials, progress of earlier agents discovered and developed previously by the investigators involved in the ..
  6. Screening for allosteric modulators of the protease activated receptor 4
    Heidi E Hamm; Fiscal Year: 2013
    ..are highly awaited in clinical medicine but Vorapaxar, a TRA that targets PAR1, was recently shown in Phase III clinical trials to increase clinically significant bleeding including intracranial hemorrhage...
  7. Prevention of ischemia reperfusion injury associated with acute myocardial infarc
    Craig Sherman; Fiscal Year: 2010
    ....
  8. PTEN Gene Therapy for Vein Graft Disease
    Christopher D Kontos; Fiscal Year: 2010
    ..Recent Phase III clinical trials of an oligonucleotide decoy targeting the E2F transcription factor demonstrated no benefit for the ..
  9. Xenon MRI assessment of response to cystic fibrosis therapies
    IULIAN CONSTANTIN RUSET; Fiscal Year: 2012
    ..The proposed study is a vital step toward determining whether HXe MRI could be a useful outcome measure in CF, something that could have tremendous clinical impact in this patient population. ..
  10. Gene-engineered adoptive T cell immunotherapy of GBM
    Laura A Johnson; Fiscal Year: 2012
    ..Immunotherapy, recently shown to be effective in several Phase III clinical trials for patients with metastatic melanoma and prostate cancer, offers a specific targeted approach for the ..
  11. Predicting toxicity and success of anti-GD2 immunotherapy of neuroblastoma
    Alice L Yu; Fiscal Year: 2013
    ..18 by Dr. Yu. Ongoing phase III clinical trials of ch14...
  12. EGFRvIII-targeted Bispecific T cell Engagers for brain tumors
    John H Sampson; Fiscal Year: 2013
    ..Notably, tumor immunotherapy has been recently validated in phase III clinical trials, leading to pivotal approvals by the FDA of at least two prototypic immune-based cancer treatments ..
  13. Erythropoietin Blockade for the Treatment of Cancer
    C Anthony Blau; Fiscal Year: 2012
    ..Erythropoietin (Epo) is the biggest drug in all of oncology. However, three published Phase III clinical trials (the Henke study in head and neck cancer, the BEST study in breast cancer and the Wright study in non-..
  14. Nonclinical Studies to Advance Novel Drug for Post-STEMI Cardiac Regeneration
    HYNDA KAREN KLEINMAN; Fiscal Year: 2010
    ..Several additional nonclinical studies with RGN-352 are required to begin Phase II and Phase III clinical trials. Funding for these FDA-required studies is requested in this grant application...
  15. Scripps Florida Product Development Partnership for smoking cessation therapeutic
    Paul J Kenny; Fiscal Year: 2011
    ..compound entering Phase II clinical trials;and 3) By year 5 of the UH3, we will have 1 compound entering Phase III clinical trials, and another 1-2 compounds entering Phase II clinical trials...
  16. Pharmacokinetics and pharmacogenomics for 13-cis retinoic acid in neuroblastoma
    Min Hee Kang; Fiscal Year: 2013
    ..Oncology Group (COG), we have been collecting plasma samples and cell pellets from multiple phase III clinical trials of neuroblastoma (A-3973, ANBL0532, ANBL0032, and ANBL0931)...
  17. Development of a kit based PET molecular imaging agent: edotreotide Ga 68 for so
    James F Kronauge; Fiscal Year: 2010
    ..The access to PET imaging biomarkers, through a multi-centered IND, would accelerate testing, help standardize imaging protocols, expand availability and have a significant impact on the fields of medicine and pharmaceuticals. ..
  18. A New Toxicity Screen to Assess Mitochondrial DNA Content and Protein Synthesis
    ROSS JOHN WHITTAKER; Fiscal Year: 2010
    ..The industry is still plagued by costly late stage attrition in phase II and phase III clinical trials. Around the turn of the millennium, lack of efficacy was the main reason clinical trials were halted...
  19. Outcome Measures and Infrastructure for Phase III Studies in Batten Disease, JNCL
    Heather Adams; Fiscal Year: 2012
    ..focus, for the first time, on establishing common ground for outcomes and infrastructure in support of Phase III Clinical Trials. To this end, we propose three specific aims: 1) To identify potential clinicaltrial endpoints for ..
  20. The Pharmacological Treatment of Fabry Disease
    JAMES ALAN SHAYMAN; Fiscal Year: 2013
    ..One such inhibitor will soon enter phase III clinical trials. Although GLA null mice do not spontaneously develop any vascular phenotype comparable to that observed ..
  21. Interactions of the angiopoietin and PD-ECGF pathways in tumor angiogenesis
    Edward L Schwartz; Fiscal Year: 2013
    ..objective responses of PNET to anti-angiogenic agents have been seen in mouse models and in randomized phase III clinical trials. Since pancreatic cancers often express multiple angiogenic factors, an objective of this proposal is to ..
  22. Leptin Signaling in Humans
    Christos S Mantzoros; Fiscal Year: 2013
    ..to obese subjects, a treatment which is currently being tested in combination with Amylin (Symlin(R)) Phase III clinical trials. However, obesity is considered a leptin resistant state...
  23. Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs....
    David W Wright; Fiscal Year: 2013
    ..of the NETT-SEC is synchronous with the NETT's overall stated purpose: to conduct large streamlined phase III clinical trials in a broad spectrum of neurological emergencies in order to reduce the morbidity and mortality of ..
  24. Targeting apoptosis via chemical design of Bcl-2 antagonists
    Maurizio Pellecchia; Fiscal Year: 2013
    ..Already, Bcl-2- targeting antisense oligonucleotides (GenasenseTM) are in Phase III clinical trials for melanoma and chronic lymphocytic leukemia (CLL), a quintessential example of a human malignancy ..
  25. Characterization of Chronic Graft-Versus-Host Disease in the Canine Model
    SCOTT STOLL GRAVES; Fiscal Year: 2013
    ..a preclinical means to investigate the biology of chronic GVHD and rapidly screen treatment approaches, Phase III clinical trials of novel agents in humans have been uniformly disappointing...
  26. Development and Application of Multi-Spectroscopic, Site-Specific (MS3) Probes of
    EDWARD EMMETT FENLON; Fiscal Year: 2010
    ..RNA has direct medical relevance as shown by RNAi therapies currently in Phase III clinical trials for eye disease (age-related macular degeneration or AMD) and in Phase II trials for viral infections (..
  27. Targeting EGFRvIII in Brain Tumors with Bispecific Antibodies
    Bryan Choi; Fiscal Year: 2013
    ..A promising alternative is the use of immunotherapy, which has ts c in phase III clinical trials, leading to pivotal approvals by the FDA of two prototypic immune-based cancer treatments within the ..
  28. Optimization of PAR4 antagonists for thrombotic disorders
    Heidi E Hamm; Fiscal Year: 2013
    ..are highly awaited in clinical medicine but Vorapaxar, a TRA that targets PAR1, was recently shown in Phase III clinical trials to increase clinically significant bleeding including intracranial hemorrhage...
  29. Commercial development of Src kinase inhibitors for oncology
    ALLEN BARNETT; Fiscal Year: 2010
    ..Tissue samples from patients in the Phase 1 trial are being procured for the development of biomarker tests to measure drug efficacy and to identify potential patient populations who are sensitive to this drug. ..
  30. CANCER CENTER SUPPORT GRANT
    Michelle M Le Beau; Fiscal Year: 2013
    ..supported, in part, by NCI cooperative agreements and contracts to conduct Phase I, Phase II, and Phase III clinical trials. The UCCCC is a full member of the Alliance (formerly members of Cancer and Leukemia Group B and ..
  31. Targeting vascular activation: a novel therapeutic strategy for Alzheimer's
    Paula Grammas; Fiscal Year: 2013
    ..Furthermore, because several vascular activation inhibitor drugs are currently FDA approved or in use in Phase III clinical trials for cancer treatment, new clinical trials with these drugs could be rapidly designed and implemented in ..
  32. Quantitative Molecular Imaging of Heart Failure by 123I-MIBG SPECT
    Edward Ficaro; Fiscal Year: 2010
    ..tools developed in Aims 1 and 2 using retrospective analysis of image data and clinical outcomes from Phase III clinical trials of cardiac 123I-MIBG imaging...
  33. Pharmacogenomics of Racial Disparities in Childhood Leukemia Outcomes
    Mary V Relling; Fiscal Year: 2010
    ..In this application, we capitalize on the most recent Children's Oncology Group (COG) phase III clinical trials, and test the hypothesis that ancestry-related genetic variation contributes to racial disparities in ..
  34. Predictive Epigenomic Biomarkers In Rectal Cancer Patients Receiving Treatment
    Dave S B Hoon; Fiscal Year: 2013
    ..We propose to validate these findings in primary rectal tumors from two large-scale multicenter phase III clinical trials of patients randomized between Total Mesorectal Excision surgery(TME) versus Pre-Radiotherapy followed ..
  35. New PET /near IR-fluorescence tools for multimodal imaging in oncology
    Richard Ting; Fiscal Year: 2013
    ..imaging probes on the polydextran ligand Lymphoseek (tilmanocept, Neoprobe), a ligand currently in phase III clinical trials as a 99mTc labeled species for detecting lymphatic breast cancer metastasis...
  36. Acquisition of a Q-TOF Mass Spectrometer
    Wei Li; Fiscal Year: 2012
    ..small-molecule drug candidates have been licensed for commercial development, including one currently in Phase III clinical trials. However, the age of the current mass spectrometer has resulted in more and more frequent breakdowns in ..
  37. Electrical impedance myography and quantitative ultrasound in Duchenne muscular d
    Seward B Rutkove; Fiscal Year: 2013
    ..increased the need for improved methods to speed the assessment of promising drugs in Phase II and Phase III clinical trials. The current biomarkers that are employed, such as the 6-minute walk test, are relatively insensitive to ..
  38. Novel Probes for Studying Treatment of CNS-based Lysosomal Storage Diseases
    JAMES ALAN SHAYMAN; Fiscal Year: 2013
    ..Finally, the ultimate impact of our work will be progress toward the first therapy for an unmet medical need, viz. CNS-based glycosphingolipidoses. ..
  39. GENETICALLY ENGINEERED VIRUSES FOR BRAIN TUMOR THERAPY
    Robert L Martuza; Fiscal Year: 2013
    ..For tumors outside the brain, OV therapy is now in Phase III clinical trials and is entering an era of increased interest by pharmaceutical companies for translation into mainstream ..
  40. Phase II Study of Rapamycin for Complicated Vascular Anomalies IND Exempt
    DENISE MARTIN ADAMS; Fiscal Year: 2012
    ..The secondary aims are to assess biomarker analysis on serum and tissue from children and young adults with vascular anomalies. Biomarkers will be tested at baseline, 6 months and 12 months on a limited number of subjects. ..
  41. MUC1 AND RESISTANCE OF CANCER CELLS TO ONCOLYTIC VIROTHERAPY
    VALERY ZURABOVICH GRDZELISHVILI; Fiscal Year: 2012
    ..Following numerous successful preclinical studies, several OVs have now entered or are entering phase III clinical trials against various cancers, and therefore, the approval of the firs OV in North America is expected in the ..
  42. Toxicity Monitoring on Phase III Trials with Administrative Data
    Richard Aplenc; Fiscal Year: 2013
    ..PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. Four hypotheses underpin this application: (1) We hypothesize that greater than 95% of patients ..
  43. HIV entry and its inhibition
    Robert W Doms; Fiscal Year: 2010
    ..membrane fusion inhibitor has been licensed (T20/enfuvirtide), three CCR5 inhibitors will be tested in Phase III clinical trials in 2005, a new CXCR4 inhibitor will soon be used in HIV-infected patients, and several other entry ..
  44. Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs (U10)
    BARNEY JOEL STERN; Fiscal Year: 2011
    ..And (2) conduct two large, streamlined phase III clinical trials involving neurological emergencies to demonstrate the capability of the Network and to stimulate general ..
  45. Prognostic markers for ovarian cancer
    Samuel C Mok; Fiscal Year: 2013
    ..These markers could be used to detect aggressive cancers and stratify patients into prognostic groups;could serve as therapeutic targets;and could facilitate patient stratification for phase III clinical trials.
  46. Establishing Drosophila Tools for Pathway Mapping and Target Identification
    ELENA M GRACHEVA; Fiscal Year: 2010
    ..came from our academic collaborators who used this approach to demonstrate activity of a drug now in Phase III clinical trials for Medullary Thyroid Carcinoma...
  47. Mechanisms That Regulate Tumor-Specific Immune Responses
    Bernard A Fox; Fiscal Year: 2013
    ..the CD4-depletion study, mentioned above, is awaiting availability of Zanolimumab (humanized anti-CD4 in Phase III clinical trials)...
  48. Preclinical Assessment of Novel Combination Therapy to Restore and Prolong Regula
    ERIK BRIAN FINGER; Fiscal Year: 2013
    ..Overall, the results from this proposed study will enable the development and translation of an immunosuppression-free protocol for clinical islet transplantation for the cure of diabetes. ..
  49. Minimal Residual Disease in Pediatric ALL in Relation to Other Prognostic Factors
    Michael J Borowitz; Fiscal Year: 2010
    ..study of large numbers of patients;thus, we will carry out these studies in association with the phase III clinical trials of the Children's Oncology Group...
  50. NOVEL CELL CYCLE REGULATION BY ADENOVIRUS E1B 55K
    David Ornelles; Fiscal Year: 2009
    DESCRIPTION (provided by applicant): Oncolytic ElB-55K-mutant adenoviruses have entered phase III clinical trials. However, the basis for their selective replication in tumor cells is poorly understood...
  51. Phase III Study of a Nicotine Vaccine for Smoking Cessation
    Paul D Kessler; Fiscal Year: 2010
    ..S. Food and Drug Administration (FDA) agreed on the design and protocols of two pivotal Phase III clinical trials for NicVAX under the Special Protocol Assessment (SPA) procedure...
  52. NEW APPROACHES TO SURGICAL ONCOLOGY
    Donald L Morton; Fiscal Year: 2013
    ..Core B (Administration and Multicenter Trial Operations Center) is a unique, complex core in charge with the administration of the grant and the operations center of the two major Phase III clinical trials.
  53. The Children's Mercy-Truman-UMKC Center: A New Addition for the Next 5 Years
    William E Truog; Fiscal Year: 2013
    ..Our Center brings substantial experience in all levels of Phase I, Phase II and Phase III clinical trials as well as other designs including crossover trials...
  54. The Blurring of Treatment and Research in Clinical Trials: two problems
    Charles W Lidz; Fiscal Year: 2010
    ....
  55. ACAT inhibitors regulate palmitoylated APP and Abeta production
    Dora M Kovacs; Fiscal Year: 2013
    ..statins reduced beta-amyloid (A?) in cells and animal models, so far yielded disappointing results in phase III clinical trials for AD...
  56. Prospective Neuroimaging in Huntington's Disease
    HERMINIA DIANA ROSAS; Fiscal Year: 2013
    ..provide the necessary sensitivity and specificity to help assess disease modification in Phase II and Phase III clinical trials. During the current funding period, we used state-of-the-art neuro-imaging tools to show that regional ..
  57. FASEB SRC on Melatonin Biology: Actions and Therapeutics
    JAMES MICHAEL OLCESE; Fiscal Year: 2013
    ..Other melatonin analogues are in phase III clinical trials for the treatment of depression, insomnia, and circadian sleep disorders (i.e...
  58. Canadian Contribution to NCI Intergroup Program
    Elizabeth Eisenhauer; Fiscal Year: 2013
    ....
  59. STEP inhibitors for intervention in Alzheimer's Disease
    Lutz Tautz; Fiscal Year: 2012
    ..The recent failure of the gamma-secretase inhibitor semagacestat in phase III clinical trials suggests that other approaches are clearly needed...
  60. CHROMOSOMAL ABNORMALITIES IN MYELOMA AS DETECTED BY FISH
    Rafael Fonseca; Fiscal Year: 2013
    ..PUBLIC HEALTH RELEVANCE: This grant proposal aims to better define which treatments should be given to which genetic subtypes of myeloma, to provide optimal and risk adapted therapy for patients. ..
  61. 2013 Malaria Gordon Research Conference and Gordon Research Seminar
    NANCY RYAN GRAY; Fiscal Year: 2013
    ....
  62. Ripple Effect of Lifestyle Intervention During Pregnancy on Partners'Weight
    Todd Alan Hagobian; Fiscal Year: 2013
    ..The proposed study is ancillary to two randomized phase III clinical trials in the LIFE-moms consortium (1U01HL114377-01, PI Phelan;3U01DK094418-01S1, PIs Martin and Redman) that ..
  63. LCDIO FOR LYMPH NODE MR IMAGING
    Ralph Weissleder; Fiscal Year: 2001
    ..abstract_text> ..
  64. Molecular Requirements for Recombinant Cytotoxins Efficacy
    Waldemar Debinski; Fiscal Year: 2010
    ..anti-glioma agents in pre- clinical evaluation, and the first generation of these cytotoxins is in Phase III clinical trials. The structure- function relationship analysis of IL13 and its recently revealed solution structure ..
  65. CLINICAL TRIALS FOR PEDIATRIC SPINAL MUSCULAR ATROPHY
    Susan Iannaccone; Fiscal Year: 2005
    ..A positive response in biologic markers after treatment will be evidence in favor of advancing to phase III clinical trials. The correlation between biologic markers and clinical outcome measures will aid in determining which ..
  66. Molecular profiles of colorectal adenomas by array CGH
    Galen Hostetter; Fiscal Year: 2009
    ..My primary mentor is Dr. Dave Alberts, principal investigator on large Phase III clinical trials on chemoprevention of colorectal adenoma recurrence. Dr. Martinez offers mentorship in epidemiology, Drs...
  67. PHOTOTHERAPY OF BLADDER CANCER: NEW PHOTOSENSITIZERS
    Chi Wei Lin; Fiscal Year: 1991
    ..b>Phase III clinical trials for HPD-phototherapy are now underway...
  68. RACIVIR FOR TREATMENT OF HEPATITIS B AND HIV INFECTIONS
    Michael Otto; Fiscal Year: 2000
    ..FTC, Coviracil, Emtricitabine], a drug with a proven safety and efficacy profile currently in Phase III clinical trials for HIV infections...
  69. Clinical Development of a Dengue Vaccine
    Beth Ann Coller; Fiscal Year: 2004
    ..that will be done at the Walter Reed Army Institute for Research and prior to continued Phase II and Phase III clinical trials. All work described in this grant application constitute a collaboration between Hawaii Biotech, Inc...
  70. PARAMEDIC FIELD INITIATION OF MAGNESIUM NEUROPROTECTIVE
    Jeffrey Saver; Fiscal Year: 2003
    ..no neuroprotective agent has yet been shown to be beneficial for humans with stroke in definitive, phase III clinical trials. A crucial, quite possibly the crucial, factor that has hindered human clinical trials of ..
  71. PRACTICAL CHEMICAL SYNTHESIS OF COMPLEX ALKALOIDS
    LARRY OVERMAN; Fiscal Year: 2009
    ..antiarrhythmic properties and low toxicity;the hetisine alkaloid guan-fu base A is currently undergoing Phase III clinical trials in China. Palau'amine is a remarkably non-toxic immunosuppressive agent...
  72. 3RD BIENNIAL MEETING--PHOTODYNAMIC ASSOCIATION
    Thomas Dougherty; Fiscal Year: 1990
    ..At the same time, multi-center Phase III clinical trials are ongoing, which will hopefully lead to the regulatory approval of PDT in the U.S. and abroad...
  73. Enhancing the immunogenicity of idiotypes for therapy of Non-Hodgkin's lymphoma
    Yvonne Paterson; Fiscal Year: 2006
    ..Currently, the best idiotype-based vaccine, which is in randomized phase III clinical trials, uses KLH as a protein carrier coupled to the B cell receptor (BCR) idiotype (Id) and GM-CSF as an ..
  74. Efficacy of Amantadine Hydochloride after Pediatric TBI
    SUE BEERS; Fiscal Year: 2002
    ..This information will optimize the design of Phase III clinical trials.
  75. SUSTAINED RELEASE CYCLOSPORINE FOR TREATMENT OF UVEITIS
    Paul Ashton; Fiscal Year: 2000
    ..adapt the experimental manufacturing process for commercialization; and 3. design the Phase III clinical trials, including selection and inspection of clinical centers...
  76. Structural Studies of the MPT64 Family of Mycobacterial Virulence Factors
    BRIAN GEISBRECHT; Fiscal Year: 2007
    ..By virtue of this relatively unique expression profile, Rv1980c is currently under phase III clinical trials in South Africa and Peru to evaluate its potential to replace tuberculin, or purified protein derivative,..
  77. ALABAMA/ZAMBIA HIV VACCINE CLINICAL TRIALS UNIT (HVTU)
    Paul Goepfert; Fiscal Year: 2006
    ..3) To prepare for future expansion to phase III clinical trials of candidate HIV vaccines in Zambia and Alabama...
  78. Outcome of Sensory-Based Intervention after Birth Trauma
    Lucy Miller; Fiscal Year: 2001
    ..The complex process of planning Phase III clinical trials is problematic in OT, because a well-established clinical research infrastructure does not exist...