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

NCT ID: NCT01933061

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abraxane 150 mg/m² Intravenous (IV)

Group Type: EXPERIMENTAL

Abraxane

Intervention Type: DRUG

Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle

CC-486 orally plus Abraxane IV

Group Type: EXPERIMENTAL

Abraxane

Intervention Type: DRUG

Abraxane 150 mg/m\^2 intravenously on Days 1, 8, and 15 of a 28-day cycle

Interventions

Abraxane

Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle

Intervention Type: DRUG

Abraxane

Abraxane 150 mg/m\^2 intravenously on Days 1, 8, and 15 of a 28-day cycle

Intervention Type: DRUG

Other Intervention Names

nab-paclitaxel, ABI-007; nab-paclitaxel, ABI-007

Eligibility Criteria

Inclusion Criteria

• 1. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).

2. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.

• Up to one prior regimen with the following classes of agents is permitted:

o Targeted biologic agents (e.g. interleukin 2 [IL-2], granulocyte macrophage colony stimulating factor [GM-CSF], other cytokines or unarmed monoclonal antibodies)

o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein [HSP] inhibitors, etc.).

• Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).
• Prior adjuvant therapy with interferon and/or vaccines is permitted.
• Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).

3. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.

• If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.

4. History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

• Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.

5. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).

6. Adequate haemtological and biochemical parameters:

• ANC ≥ 1.5 x 109 cells/L.
• Platelets ≥ 100 x 109 cells/L.
• Hgb ≥ 9 g/dL.
• AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);

o ≤ 5.0 x ULN if hepatic metastases present.

• Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL. 8. ECOG performance status 0 to 1.

Exclusion Criteria

• 1. History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.

2. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.

3. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Hege, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Other Identifiers

CC-486-MEL-001

Identifier Type: -

Identifier Source: org_study_id