At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic melanoma
- ✓≤1 prior systemic therapy for metastatic disease (prior adjuvant interferon does not count)
- ✕History of hemoptysis
- ✕Brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Axitinib [AG-013736] for Melanoma and Skin Neoplasms. Completed, enrolled 32 participants across 12 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.