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Sponsored by: |
CuraGen Corporation |
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Information provided by: | CuraGen Corporation |
ClinicalTrials.gov Identifier: | NCT00412828 |
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
Condition | Intervention | Phase |
---|---|---|
Unresectable Stage III or Stage IV Melanoma |
Drug: CR011-vcMMAE |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma |
Estimated Enrollment: | 135 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
Contact: CuraGen Clinical Trial Call Center | 1-877-462-4363 | info@curagen.com |
United States, California | |
Angeles Clinic and Research Institute | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Omid Hamid, MD 310-231-2121 ohamid@theangelesclinic.org | |
Principal Investigator: Steven O'Day, MD | |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Call For Information 877-462-4363 info@curagen.com | |
Principal Investigator: Mario Sznol, M.D. | |
United States, New York | |
New York University Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Call for Information 877-462-4363 info@curagen.com | |
Principal Investigator: Anna Pavlick, DO | |
United States, Texas | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Call For Information 877-462-4363 info@curagen.com | |
Principal Investigator: Patrick Hwu, M.D. |
Responsible Party: | CuraGen Corporation ( Vice President, Regulatory Affairs and Quality Assurance. ) |
Study ID Numbers: | CR011-CLN-11 |
Study First Received: | December 18, 2006 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00412828 |
Health Authority: | United States: Food and Drug Administration |
Melanoma CR011-vcMMAE |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |