Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

Celgene

Status and phase

Completed

Phase 3

Conditions

Melanoma

Neoplasm Metastasis

Treatments

Drug: CC-5013

Study type

Interventional

Funder types

Industry

Identifiers

NCT00057616

CC-5013-MEL-002

Details and patient eligibility

About

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Understand and voluntarily sign an informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.