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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00057616

Collaborator

ICON Clinical Research (Industry)

274

Enrollment

Locations

33.4

Actual Duration (Months)

5.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Neoplasm Metastasis	Drug: CC-5013	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

Jul 15, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Canberra Hospital	Garran	Australian Capital Territory	Australia	2605
2	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
3	Sydney Cancer Centre	Camperdown	New South Wales	Australia	2145
4	Royal Newcastle Hospital	Newcastle	New South Wales	Australia	2300
5	Westmead Hospital	Westmead	New South Wales	Australia	2145
6	Roayl Brisbane Hospital	Herston	Queensland	Australia	4029
7	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
8	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
9	Royal Hobart Hospital	Hobart	Tasmania	Australia	7001
10	Cabrini Hospital	Malvern	Victoria	Australia	3144
11	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
12	Mount HospitalOncology	Perth	Western Australia	Australia	6009
13	North-Estonian Regional Hospital	Tallinn		Estonia	11619
14	Tartu University Clinics Onkology & Haematology Clinic	Tartu		Estonia	51003
15	Klinick fur Dermatologie	Berlin		Germany	D-10117
16	Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital	Bochum		Germany	44791
17	Klinick fur Dermatolgie	Bonn		Germany	53105
18	Universitatsklinikum Freiburg	Freiburg		Germany	79104
19	Universitatsklinik Eppendorf	Hamburg		Germany	D-20246
20	Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie	Kiel		Germany	D-24105
21	Klinik fur DermatologieVenerologie und Allergologie	Mannheim		Germany	D-68135
22	Latvian Onkology Centre	Riga		Latvia	LV-1079
23	Klaipeda Hospital	Klaipeda		Lithuania	LT-5808
24	Vilnius University Onkology Institute	Vilnius		Lithuania	LT-2600
25	Daniel DenHoed Kliniek	Rotterdam		Netherlands
26	Panorama Medi-Clinic / Panorama Oncology Unit	Cape Town		South Africa	7506
27	Addington Hospital	Durban		South Africa	4001
28	Wilgers Hospital / Wilgers Oncology Centre	Hatfield, Pretoria		South Africa	0028
29	Sandton Oncology Centre	Morningside, Johannesburg		South Africa
30	St. Georges Hospital	Port Elizabeth		South Africa	6001
31	Little Company of Mary / Mary Potter Oncology Centre	Pretoria		South Africa	0002
32	Pretoria Academic Hospital / Department Medical Oncology	Pretoria		South Africa
33	Durban Oncology Centre	Westridge, Durban		South Africa	4001
34	Dnipropetrovsk State Medical Academy	Dnipropetrovsk		Ukraine
35	Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center	Kharkov		Ukraine	61070
36	Scientific Research Institute of OncologySoft Tissue Department	Kiev		Ukraine	03022
37	Kiev City Oncology Hospital	Kiev		Ukraine	3115
38	Lviv State Medical University Regional Oncology Centre	Lviv		Ukraine	79010
39	Odessa Regional Oncology DispensaryChemotherapy Dept	Odessa		Ukraine	65055
40	Uzhgorod Regional Oncology Diepensary	Uzhgorod		Ukraine	88000
41	Cancer Centre	Egbaston	Birmingham	United Kingdom	B15 2TH
42	Christies Hospital	Withington	Manchester	United Kingdom	M2O 4BX
43	Beatson Oncology CentreWestern InfirmaryOncology	Glasgow		United Kingdom	G11 6NT
44	Cancer Research BldgDivsion of Cancer Medicine Research	Leeds		United Kingdom	LS9 7TF
45	Roayl Free Hospital	London		United Kingdom	NW3 2QG
46	St. George's Hospital	London		United Kingdom	SW17 0QT
47	Royal Marsden Hospital Department of Oncology	London		United Kingdom	SW3 6JJ
48	Royal Marsden Hospital	London		United Kingdom
49	Newcastle GeneralOncology	Newcastle		United Kingdom	NE4 6BE