NCT01933061

Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma

A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.

Detailed description

The study will consist of the following phases: * Screening (Baseline) Assessments: Performed within 21 days of randomization. * Randomization: Subjects will be randomized within 21 days of starting their Baseline assessments. * Treatment: Therapy may continue in the absence of clinically significant disease progression and unacceptable toxicity. * Response Assessments: Subjects will be evaluated by investigators for CR, PR, stable or progressive disease every 6 weeks from the start of treatment until progressive disease is documented. Responders and subjects with stable disease (SD) should continue on study unless they develop unacceptable toxicity, they start a new anticancer therapy, withdrawal of consent, physician decision or death. * End of Study (EOS)/Treatment Evaluation: At the time subjects are removed from study, laboratory and clinical evaluations will be performed. * Follow-up for Disease Progression: \- Subjects who stop treatment prior to developing disease progression should be followed without further treatment until progressive disease is documented or until the treating physician feels additional treatment is required. * Follow-up for Survival: * Post study, subject survival status will be monitored on a monthly basis for 6 months from discontinuation from the study and every 3 months thereafter, until death or study termination in all subjects.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Abraxane	Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle
DRUG	Abraxane	Abraxane 150 mg/m\^2 intravenously on Days 1, 8, and 15 of a 28-day cycle

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-08-30
• Last updated: 2014-02-04