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

Primary Purpose

Melanoma, Neoplasm Metastasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CC-5013
Sponsored by
Celgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring Metastatic Melanoma, Melanoma, Revimid, CC5013

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Canberra Hospital
  • Royal Prince Alfred Hospital
  • Sydney Cancer Centre
  • Royal Newcastle Hospital
  • Westmead Hospital
  • Roayl Brisbane Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Cabrini Hospital
  • Sir Charles Gairdner Hospital
  • Mount HospitalOncology
  • North-Estonian Regional Hospital
  • Tartu University Clinics Onkology & Haematology Clinic
  • Klinick fur Dermatologie
  • Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
  • Klinick fur Dermatolgie
  • Universitatsklinikum Freiburg
  • Universitatsklinik Eppendorf
  • Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
  • Klinik fur DermatologieVenerologie und Allergologie
  • Latvian Onkology Centre
  • Klaipeda Hospital
  • Vilnius University Onkology Institute
  • Daniel DenHoed Kliniek
  • Panorama Medi-Clinic / Panorama Oncology Unit
  • Addington Hospital
  • Wilgers Hospital / Wilgers Oncology Centre
  • Sandton Oncology Centre
  • St. Georges Hospital
  • Little Company of Mary / Mary Potter Oncology Centre
  • Pretoria Academic Hospital / Department Medical Oncology
  • Durban Oncology Centre
  • Dnipropetrovsk State Medical Academy
  • Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
  • Scientific Research Institute of OncologySoft Tissue Department
  • Kiev City Oncology Hospital
  • Lviv State Medical University Regional Oncology Centre
  • Odessa Regional Oncology DispensaryChemotherapy Dept
  • Uzhgorod Regional Oncology Diepensary
  • Cancer Centre
  • Christies Hospital
  • Beatson Oncology CentreWestern InfirmaryOncology
  • Cancer Research BldgDivsion of Cancer Medicine Research
  • Roayl Free Hospital
  • St. George's Hospital
  • Royal Marsden Hospital Department of Oncology
  • Royal Marsden Hospital
  • Newcastle GeneralOncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 4, 2003
Last Updated
November 6, 2019
Sponsor
Celgene
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00057616
Brief Title
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2002 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 15, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
ICON Clinical Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Neoplasm Metastasis
Keywords
Metastatic Melanoma, Melanoma, Revimid, CC5013

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
274 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sydney Cancer Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Newcastle Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Roayl Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Mount HospitalOncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
North-Estonian Regional Hospital
City
Tallinn
ZIP/Postal Code
11619
Country
Estonia
Facility Name
Tartu University Clinics Onkology & Haematology Clinic
City
Tartu
ZIP/Postal Code
51003
Country
Estonia
Facility Name
Klinick fur Dermatologie
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinick fur Dermatolgie
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Universitatsklinik Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Klinik fur DermatologieVenerologie und Allergologie
City
Mannheim
ZIP/Postal Code
D-68135
Country
Germany
Facility Name
Latvian Onkology Centre
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Klaipeda Hospital
City
Klaipeda
ZIP/Postal Code
LT-5808
Country
Lithuania
Facility Name
Vilnius University Onkology Institute
City
Vilnius
ZIP/Postal Code
LT-2600
Country
Lithuania
Facility Name
Daniel DenHoed Kliniek
City
Rotterdam
Country
Netherlands
Facility Name
Panorama Medi-Clinic / Panorama Oncology Unit
City
Cape Town
ZIP/Postal Code
7506
Country
South Africa
Facility Name
Addington Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Wilgers Hospital / Wilgers Oncology Centre
City
Hatfield, Pretoria
ZIP/Postal Code
0028
Country
South Africa
Facility Name
Sandton Oncology Centre
City
Morningside, Johannesburg
Country
South Africa
Facility Name
St. Georges Hospital
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Little Company of Mary / Mary Potter Oncology Centre
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Pretoria Academic Hospital / Department Medical Oncology
City
Pretoria
Country
South Africa
Facility Name
Durban Oncology Centre
City
Westridge, Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Scientific Research Institute of OncologySoft Tissue Department
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kiev City Oncology Hospital
City
Kiev
ZIP/Postal Code
3115
Country
Ukraine
Facility Name
Lviv State Medical University Regional Oncology Centre
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odessa Regional Oncology DispensaryChemotherapy Dept
City
Odessa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Uzhgorod Regional Oncology Diepensary
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Cancer Centre
City
Egbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Christies Hospital
City
Withington
State/Province
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Facility Name
Beatson Oncology CentreWestern InfirmaryOncology
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Cancer Research BldgDivsion of Cancer Medicine Research
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Roayl Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden Hospital Department of Oncology
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
Newcastle GeneralOncology
City
Newcastle
ZIP/Postal Code
NE4 6BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19862820
Citation
Eisen T, Trefzer U, Hamilton A, Hersey P, Millward M, Knight RD, Jungnelius JU, Glaspy J. Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma. Cancer. 2010 Jan 1;116(1):146-54. doi: 10.1002/cncr.24686.
Results Reference
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Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

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