NCT00057616 is a Phase 3 clinical trial of CC-5013 in Melanoma, sponsored by Celgene.

Who is sponsoring NCT00057616?

NCT00057616 is sponsored by Celgene.

What drugs are being tested in NCT00057616?

Interventions in NCT00057616: CC-5013.

What condition does NCT00057616 study?

NCT00057616 studies Melanoma, Neoplasm Metastasis.

Is NCT00057616 still recruiting?

NCT00057616 is currently completed. Last updated 8 November 2019.

Last reviewed 2019-11-08 · How we verify

NCT00057616

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 8 November 2019

What this trial tests

Phase 3 trial testing CC-5013 in Melanoma in 274 participants. Completed in 15 July 2005.

Timeline

1 October 2002

15 July 2005

Quick facts

Lead sponsor	Celgene
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	274
Start date	1 October 2002
Estimated completion	15 July 2005
Sites	49 locations across South Africa, Netherlands, Ukraine, Estonia, United Kingdom, Germany, Lithuania, Australia

Drugs / interventions tested

CC-5013 — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Melanoma or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of CC-5013

Trials testing the same drug.

NCT00179608 — Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previousl · Phase 1 · completed
NCT00065351 — Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma · Phase 2 · completed
NCT00622336 — A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma · Phase 3 · completed
NCT00056160 — CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Phase 3 · completed
NCT00044382 — Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome · Phase 2 · completed

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00057616 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 8 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00057616.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing