NCT00483301

A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Sorafenib (BAY 43-9006)	dosage
DRUG	ABI-007(Abraxane)	dosage

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-06-07
• Last updated: 2012-05-03

Locations

2 sites across 1 country: United States