NCT00094107

Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma
• Skin Neoplasms

Interventions

Type	Name	Description
DRUG	Axitinib [AG-013736]	VEGFR \[vascular endothelial growth factor Receptor\] and PDGFR \[Platelet-Derived Growth Factor Receptor\] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2004-10-14
• Last updated: 2012-06-26
• Results posted: 2012-03-30

Locations

12 sites across 2 countries: United States, France