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

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.

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Key information

Conditions

Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Canberra Hospital, Garran, Australian Capital Territory, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-5013

Drug

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Collaborators

ICON Clinical Research

Registry information

Official study title

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Important dates

Study start: 2002
Study completion: 2005
First posted: Apr 7, 2003
Registry last updated: Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed