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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00086489 |
The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma
Condition | Intervention | Phase |
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Malignant Melanoma |
Drug: CP-675,206 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Open Label, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Immune Function Effects, And Efficacy Of Multiple Doses Of CP-675,206 In Patients With Advanced Melanoma, And Phase 2, Open Label, Randomized Study To Evaluate the Efficacy, Safety, Tolerability And Pharmacokinetics Of 2 Regimens Of CP-675,206 In Patients With Advanced Melanoma. |
Estimated Enrollment: | 125 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
10 mg/kg: Experimental
pts treated at 10 mg/kg dose level on a monthly regimen
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Drug: CP-675,206
pts treated at 10 mg/kg dose level on a monthly regimen
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15 mg/kg: Experimental
pts treated at 15 mg/kg dose level on a quarterly regimen
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Drug: CP-675,206
pts treated at 15 mg/kg dose level on a quarterly regimen
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
Pfizer Investigational Site | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Pfizer Investigational Site | |
Chicago, Illinois, United States, 60637-1460 | |
United States, Michigan | |
Pfizer Investigational Site | |
Ann Arbor, Michigan, United States, 48109-0008 | |
Pfizer Investigational Site | |
Ann Arbor, Michigan, United States, 48109-0843 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Pfizer Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15232-1305 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Pfizer Investigational Site | |
Houston, Texas, United States, 77030 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3671002 |
Study First Received: | July 1, 2004 |
Last Updated: | January 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00086489 |
Health Authority: | United States: Food and Drug Administration |
metastatic melanoma, multiple dose |
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 |