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

Celgene274 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

274

Conditions

Melanoma Neoplasm Metastasis

Interventions

CC-5013DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (49)

Data from ClinicalTrials.gov

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The Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Sydney Cancer Centre

Camperdown, New South Wales, Australia

Royal Newcastle Hospital

Newcastle, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Roayl Brisbane Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Cabrini Hospital

Malvern, Victoria, Australia

...and 39 more locations