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

November 6, 2019 updated by: Celgene

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Camperdown, New South Wales, Australia, 2145
        • Sydney cancer centre
      • Newcastle, New South Wales, Australia, 2300
        • Royal Newcastle Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Roayl Brisbane Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6009
        • Mount HospitalOncology
  • Estonia
      • Tallinn, Estonia, 11619
        • North-Estonian Regional Hospital
      • Tartu, Estonia, 51003
        • Tartu University Clinics Onkology & Haematology Clinic
  • Germany
      • Berlin, Germany, D-10117
        • Klinick fur Dermatologie
      • Bochum, Germany, 44791
        • Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
      • Bonn, Germany, 53105
        • Klinick fur Dermatolgie
      • Freiburg, Germany, 79104
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, D-20246
        • Universitätsklinik Eppendorf
      • Kiel, Germany, D-24105
        • Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
      • Mannheim, Germany, D-68135
        • Klinik fur DermatologieVenerologie und Allergologie
  • Latvia
      • Riga, Latvia, LV-1079
        • Latvian Onkology Centre
  • Lithuania
      • Klaipeda, Lithuania, LT-5808
        • Klaipeda Hospital
      • Vilnius, Lithuania, LT-2600
        • Vilnius University Onkology Institute
  • Netherlands
      • Rotterdam, Netherlands
        • Daniel DenHoed Kliniek
  • South Africa
      • Cape Town, South Africa, 7506
        • Panorama Medi-Clinic / Panorama Oncology Unit
      • Durban, South Africa, 4001
        • Addington Hospital
      • Hatfield, Pretoria, South Africa, 0028
        • Wilgers Hospital / Wilgers Oncology Centre
      • Morningside, Johannesburg, South Africa
        • Sandton Oncology Centre
      • Port Elizabeth, South Africa, 6001
        • St. Georges Hospital
      • Pretoria, South Africa, 0002
        • Little Company of Mary / Mary Potter Oncology Centre
      • Pretoria, South Africa
        • Pretoria Academic Hospital / Department Medical Oncology
      • Westridge, Durban, South Africa, 4001
        • Durban Oncology Centre
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Dnipropetrovsk State Medical Academy
      • Kharkov, Ukraine, 61070
        • Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
      • Kiev, Ukraine, 03022
        • Scientific Research Institute of OncologySoft Tissue Department
      • Kiev, Ukraine, 3115
        • Kiev City Oncology Hospital
      • Lviv, Ukraine, 79010
        • Lviv State Medical University Regional Oncology Centre
      • Odessa, Ukraine, 65055
        • Odessa Regional Oncology DispensaryChemotherapy Dept
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod Regional Oncology Diepensary
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology CentreWestern InfirmaryOncology
      • Leeds, United Kingdom, LS9 7TF
        • Cancer Research BldgDivsion of Cancer Medicine Research
      • London, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, United Kingdom
        • Royal Marsden Hospital
      • London, United Kingdom, NW3 2QG
        • Roayl Free Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital Department of Oncology
      • Newcastle, United Kingdom, NE4 6BE
        • Newcastle GeneralOncology
    • Birmingham
      • Egbaston, Birmingham, United Kingdom, B15 2TH
        • Cancer Centre
    • Manchester
      • Withington, Manchester, United Kingdom, M2O 4BX
        • Christies Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Collaborators

ICON Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2002

Study Completion (Actual)

July 15, 2005

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 8, 2003

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MEL-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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