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

• Status: Withdrawn
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.