Malignant Melanoma Clinical Trial
Official title:
A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma
The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.
The primary objective of this phase II multicenter trial is to:
Measure the response rate (RR) of this combination and schedule in patients with metastatic
melanoma
The secondary objectives are to:
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
Determine overall survival (OS)
STUDY DESIGN
This will be a Phase II study single arm study with a two-stage design with a maximum sample
size of 43 patients, 18 in the first stage and 25 in the second stage.
Study duration: A minimum yearly accrual of 10-15 patients/institution is expected.
Therefore, to reach the first stage, the study will take 1.2 to 1.8 years with one
institution, 0.6 to 0.9 years with 2 institutions, and 0.4 to 0.6 years with 3. If the study
continues to full accrual to 43 patients, completion will take 2.9 to 4.3 years with one
institution, 1.4 to 2.2 years with two and 0.96 to 1.43 years with three institutions.
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