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
1 other identifier
interventional
274
9 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2002
Typical duration for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 4, 2003
CompletedFirst Posted
Study publicly available on registry
April 7, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2005
CompletedNovember 8, 2019
November 1, 2019
April 4, 2003
November 6, 2019
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Celgenelead
- ICON Clinical Researchcollaborator
Study Sites (49)
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Sydney Cancer Centre
Camperdown, New South Wales, 2145, Australia
Royal Newcastle Hospital
Newcastle, New South Wales, 2300, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Roayl Brisbane Hospital
Herston, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7001, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Mount HospitalOncology
Perth, Western Australia, 6009, Australia
North-Estonian Regional Hospital
Tallinn, 11619, Estonia
Tartu University Clinics Onkology & Haematology Clinic
Tartu, 51003, Estonia
Klinick fur Dermatologie
Berlin, D-10117, Germany
Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
Bochum, 44791, Germany
Klinick fur Dermatolgie
Bonn, 53105, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79104, Germany
Universitatsklinik Eppendorf
Hamburg, D-20246, Germany
Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
Kiel, D-24105, Germany
Klinik fur DermatologieVenerologie und Allergologie
Mannheim, D-68135, Germany
Latvian Onkology Centre
Riga, LV-1079, Latvia
Klaipeda Hospital
Klaipėda, LT-5808, Lithuania
Vilnius University Onkology Institute
Vilnius, LT-2600, Lithuania
Daniel DenHoed Kliniek
Rotterdam, Netherlands
Panorama Medi-Clinic / Panorama Oncology Unit
Cape Town, 7506, South Africa
Addington Hospital
Durban, 4001, South Africa
Wilgers Hospital / Wilgers Oncology Centre
Hatfield, Pretoria, 0028, South Africa
Sandton Oncology Centre
Morningside, Johannesburg, South Africa
St. Georges Hospital
Port Elizabeth, 6001, South Africa
Little Company of Mary / Mary Potter Oncology Centre
Pretoria, 0002, South Africa
Pretoria Academic Hospital / Department Medical Oncology
Pretoria, South Africa
Durban Oncology Centre
Westridge, Durban, 4001, South Africa
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine
Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
Kharkiv, 61070, Ukraine
Scientific Research Institute of OncologySoft Tissue Department
Kiev, 03022, Ukraine
Kiev City Oncology Hospital
Kiev, 3115, Ukraine
Lviv State Medical University Regional Oncology Centre
Lviv, 79010, Ukraine
Odessa Regional Oncology DispensaryChemotherapy Dept
Odesa, 65055, Ukraine
Uzhgorod Regional Oncology Diepensary
Uzhhorod, 88000, Ukraine
Cancer Centre
Egbaston, Birmingham, B15 2TH, United Kingdom
Christies Hospital
Withington, Manchester, M2O 4BX, United Kingdom
Beatson Oncology CentreWestern InfirmaryOncology
Glasgow, G11 6NT, United Kingdom
Cancer Research BldgDivsion of Cancer Medicine Research
Leeds, LS9 7TF, United Kingdom
Roayl Free Hospital
London, NW3 2QG, United Kingdom
St. George's Hospital
London, SW17 0QT, United Kingdom
Royal Marsden Hospital Department of Oncology
London, SW3 6JJ, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Newcastle GeneralOncology
Newcastle, NE4 6BE, United Kingdom
Related Publications (1)
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.
PMID: 19862820BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2003
First Posted
April 7, 2003
Study Start
October 1, 2002
Study Completion
July 15, 2005
Last Updated
November 8, 2019
Record last verified: 2019-11