MelanomaPhase 3NCT00057616
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
A Phase 3 study testing CC-5013 in people with Melanoma and Neoplasm Metastasis, run by Celgene at 49 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Neoplasm Metastasis
- What is being tested?
- CC-5013
- How many people
- 274 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 1 Oct 2002to 15 Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Australia12 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Sydney Cancer Centre
Camperdown, New South Wales, 2145
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Roayl Brisbane Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7001
Cabrini Hospital
Malvern, Victoria, 3144
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Newcastle Hospital
Newcastle, New South Wales, 2300
Mount HospitalOncology
Perth, Western Australia, 6009
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
United Kingdom9 sites
Cancer Centre
Egbaston, Birmingham, B15 2TH
Beatson Oncology CentreWestern InfirmaryOncology
Glasgow, G11 6NT
Cancer Research BldgDivsion of Cancer Medicine Research
Leeds, LS9 7TF
Roayl Free Hospital
London, NW3 2QG
St. George's Hospital
London, SW17 0QT
Royal Marsden Hospital Department of Oncology
London, SW3 6JJ
Royal Marsden Hospital
London
Newcastle GeneralOncology
Newcastle, NE4 6BE
Christies Hospital
Withington, Manchester, M2O 4BX
South Africa8 sites
Panorama Medi-Clinic / Panorama Oncology Unit
Cape Town, 7506
Addington Hospital
Durban, 4001
Wilgers Hospital / Wilgers Oncology Centre
Hatfield, Pretoria, 0028
Sandton Oncology Centre
Morningside, Johannesburg
St. Georges Hospital
Port Elizabeth, 6001
Little Company of Mary / Mary Potter Oncology Centre
Pretoria, 0002
Pretoria Academic Hospital / Department Medical Oncology
Pretoria
Durban Oncology Centre
Westridge, Durban, 4001
Germany7 sites
Klinick fur Dermatologie
Berlin, D-10117
Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
Bochum, 44791
Klinick fur Dermatolgie
Bonn, 53105
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79104
Universitatsklinik Eppendorf
Hamburg, D-20246
Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
Kiel, D-24105
Klinik fur DermatologieVenerologie und Allergologie
Mannheim, D-68135
Ukraine7 sites
Dnipropetrovsk State Medical Academy
Dnipropetrovsk
Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
Kharkiv, 61070
Scientific Research Institute of OncologySoft Tissue Department
Kiev, 03022
Kiev City Oncology Hospital
Kiev, 3115
Lviv State Medical University Regional Oncology Centre
Lviv, 79010
Odessa Regional Oncology DispensaryChemotherapy Dept
Odesa, 65055
Uzhgorod Regional Oncology Diepensary
Uzhhorod, 88000
Estonia2 sites
North-Estonian Regional Hospital
Tallinn, 11619
Tartu University Clinics Onkology & Haematology Clinic
Tartu, 51003
Lithuania2 sites
Klaipeda Hospital
Klaipėda, LT-5808
Vilnius University Onkology Institute
Vilnius, LT-2600
About this study
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
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.
- Conditions
- Melanoma, Neoplasm Metastasis
- Being tested
- CC-5013
- Keywords
- Metastatic Melanoma, Melanoma, Revimid, CC5013
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2003 (estimated)
- Study start1 Oct 2002
- Study completion15 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 274 participants
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057616
- Sponsor's protocol ID
- CC-5013-MEL-002
- Status last verified
- Nov 2019
- First submitted
- 4 Apr 2003
- Last updated
- 8 Nov 2019
- Results posted
- No
Publications
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.
PubMed 19862820
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00057616
- Acronym / sponsor ID
- CC-5013-MEL-002
- Conditions
- Melanoma, Neoplasm Metastasis
- Keywords
- Metastatic Melanoma, Melanoma, Revimid, CC5013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 1 Oct 2002 (actual)
- Study completion
- 15 Jul 2005 (actual)
- First posted
- 7 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-5013 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 19862820Eisen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CC-5013 in people with Melanoma and Neoplasm Metastasis, run by Celgene at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Australia, United Kingdom, South Africa, Germany, Ukraine and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.