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

Phase 3

Completed

• Conditions: Melanoma; Neoplasm Metastasis

• Registration Number: NCT00057616
• Lead Sponsor: Celgene

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10-01
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-08
• Study Completion: 2005-07-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (49)

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

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