Trial | NCT00057616  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    274
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 Started
Oct 01
2002
Study Completion
Jul 15
2005
Last Update
Nov 08
2019

Drug CC-5013

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.
No Results Posted