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Sponsored by: |
Medarex |
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Information provided by: | Medarex |
ClinicalTrials.gov Identifier: | NCT00323882 |
This is a multicenter study in which up to 34 patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, will receive MDX-010 every 3 weeks for 4 doses (12 weeks total duration). MDX-010 will be administered at escalating dosage levels of 3, 5, 7.5 and 10 mg/kg/dose infusions. At least 6 patients will be enrolled in each dosage level. A total of 16 patients will be enrolled at the maximum tolerated dosage level. Patients will be followed for 1 year or until disease progression. Patients who tolerate and respond to treatment or who have stable disease for 3 months or longer and who subsequently progress during the follow up phase of the study may have the option to receive additional treatment with MDX-010.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer Neoplasm Metastasis |
Drug: MDX-010 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open-Label, Dose-Escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer |
Estimated Enrollment: | 34 |
Study Start Date: | February 2005 |
This is a multicenter Phase I/II, open-label, dose-escalation study. Up to 34 chemotherapy- and immunotherapy-naive patients with metastatic hormone refractory prostate cancer will be administered intravenous (iv) infusions of MDX-010 every 3 weeks for 4 doses at escalating dosage levels of 3, 5, 7.5, and 10 mg/kg/dose. At least 6 patients will be enrolled at each dose level. Upon establishment of a maximum tolerated dose (MTD), additional patients, to accrue a total of 16 patients at the MTD dose level, will be enrolled to collect additional data for safety, tolerability, pharmacokinetics, and activity.
The duration of treatment for patients is 12 weeks; MDX-010 will be administered on Days 1, 22, 43, and 64. Evaluations to assess clinical response will be performed on Day 85. Patients will then be followed for approximately 1 year or until disease progression. The study duration for each individual patient is up to 16 months. Patients who tolerate or respond to initial therapy with MDX-010 or who have stable disease of 3 months or greater and who subsequently progress during the follow up phase will have the option to enroll in an extension protocol to receive additional cycles of MDX-010 therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Kelly | 908-479-2505 | akelly@medarex.com |
Contact: Katelyn Powers | 908-479-2642 | kpowers@medarex.com |
United States, California | |
The Angeles Clinic and Research Institute | Recruiting |
Los Angeles, California, United States, 90025 | |
Principal Investigator: Tanya B Dorff, MD | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Principal Investigator: Eric J. Small, MD | |
The Angeles Clinic and Research Institute | Recruiting |
Los Angeles, California, United States, 11818 | |
Principal Investigator: Omid Hamid, M.D. | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Principal Investigator: Andrea Harzstark, MD | |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Principal Investigator: Wm K Kelly, DO | |
United States, Michigan | |
Henry Ford Hospital | Recruiting |
Detroit, Michigan, United States, 48202-2689 | |
Principal Investigator: Sheela Tejwani, MD | |
Henry Ford Medical Center-Fairlane | Recruiting |
Dearborn, Michigan, United States, 48126 | |
Principal Investigator: Sheela Tejwani, MD | |
Henry Ford Medical Center-West Bloomfield | Recruiting |
West Bloomfield, Michigan, United States, 48322 | |
Principal Investigator: Sheela Tejwani, MD | |
Josephine Ford Cancer Center-Downriver | Recruiting |
Brownstown, Michigan, United States, 48183 | |
Principal Investigator: Sheela Tejwani, MD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Principal Investigator: Joel Picus, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Principal Investigator: Susan F Slovin, MD, PhD | |
United States, North Carolina | |
Carolina BioOncology Institute | Recruiting |
Huntersville, North Carolina, United States, 28078 | |
Principal Investigator: John D Powderly, II, MD | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Principal Investigator: Tomasz M Beer, MD | |
United States, Washington | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Principal Investigator: Celestia Higano, MD | |
University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195 | |
Principal Investigator: Celestia Higano, MD |
Study Director: | Israel Lowy, MD | Medarex |
Study ID Numbers: | MDX010-21 |
Study First Received: | May 8, 2006 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00323882 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer Oncology Prostate Cancer |
Metastatic Hormone PSA Metastatic Hormone-Refractory Prostate Cancer (HRPC) |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |