At a glance
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Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study
In Brief
A Phase 2 clinical trial evaluating Avastin and Abraxane for Metastatic Malignant Melanoma. Completed, enrolled 50 participants across 2 sites.
Detailed Summary
The study is an open-label, single arm multicenter Phase II study to evaluate the safety and efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with unresectable metastatic malignant melanoma. The patient sample will be approximately 50 individuals, males and females 18 years of age or older with measurable metastatic melanoma. Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for disease progression every 2 months and those who do not have disease progression or unacceptable toxicity will be offered ongoing therapy until they have progressive disease or unacceptable toxicity.
Study Details
Timeline
Interventions
Avastin 10 mg/kg IV every 2 weeks (without rest period).
Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle.