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

NCT01933061 | Withdrawn Phase 2

• 1 other identifier: CC-486-MEL-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Melanoma

Keywords

Skin cancer, Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the time from randomization date to disease progression according to RECIST response guideline

  Up to 24 months

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 24 months

• PFS

  Up to 24 months

• Objective Response Rate (ORR)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Safety

  Up to 24 months

Study Arms (2)

Abraxane 150 mg/m² Intravenous (IV)

EXPERIMENTAL

Drug: Abraxane

CC-486 orally plus Abraxane IV

EXPERIMENTAL

Drug: Abraxane

Interventions

Abraxane DRUG

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

Also known as: nab-paclitaxel, ABI-007

Abraxane 150 mg/m² Intravenous (IV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).
• \. 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).
• \. 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.
• \. 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.
• \. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).
• \. Adequate haemtological and biochemical parameters:
• ANC ≥ 1.5 x 109 cells/L.

You may not qualify if:

• \. 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.
• \. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
• \. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.

Sponsors & Collaborators

• Celgene Corporation: lead

MeSH Terms

Conditions

Melanoma

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Kirsten Hege, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: August 30, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 4, 2014

Record last verified: 2014-02