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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Progression-free survival (PFS)
PFS is defined as the time from randomization date to disease progression according to RECIST response guideline
Time frame: Up to 24 months
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death.
Time frame: Up to 24 months
PFS
PFS based on investigator assessment; PFS is defined as the time from randomization date to disease progression according to RECIST response guideline
Time frame: Up to 24 months
Objective Response Rate (ORR)
Number (%) of subject who achieve an objective complete or partial response.
Time frame: Up to 24 months
Disease Control Rate (DCR)
Number (%) of subject with Stable Disease (SD) ≥ for 18 weeks or complete or partial response.
Time frame: Up to 24 months
Safety
Incidence and severity of Adverse events (AE) will be analyzed in terms of treatment-emergent AEs defined to be any AE that begin or worsen in severity after study drug initiation.
Time frame: Up to 24 months
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