Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00094107 |
This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.
Condition | Intervention | Phase |
---|---|---|
Melanoma Skin Neoplasms |
Drug: VEGFR and PDGFR inhibitor, AG-013736, Axitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma |
Enrollment: | 32 |
Study Start Date: | December 2004 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: VEGFR and PDGFR inhibitor, AG-013736, Axitinib
single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.
|
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 | |
Orange, California, United States, 92868 | |
United States, Florida | |
Pfizer Investigational Site | |
Aventura, Florida, United States, 33180 | |
Pfizer Investigational Site | |
MIAMI BEACH, Florida, United States, 33140 | |
Pfizer Investigational Site | |
Miami Beach, Florida, United States, 33140 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Pfizer Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15232-1305 | |
France | |
Pfizer Investigational Site | |
Paris Cedex 13, France, 75651 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4061015 |
Study First Received: | October 11, 2004 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00094107 |
Health Authority: | United States: Food and Drug Administration |
melanoma, antiangiogenesis |
Neuroectodermal Tumors Skin Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Skin Neoplasms Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |