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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00057616




Trial ID
NCT00057616
Ethics application status
Date submitted
4/04/2003
Date registered
4/04/2003
Date last updated
25/04/2017

Titles & IDs
Public title
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Scientific 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
Secondary ID [1] 0 0
CC-5013-MEL-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-5013

Treatment: Drugs: CC-5013


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Sydney Cancer Centre - Camperdown
Recruitment hospital [4] 0 0
Royal Newcastle Hospital - Newcastle
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Roayl Brisbane Hospital - Herston
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 0 0
Mount HospitalOncology - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2145 - Camperdown
Recruitment postcode(s) [4] 0 0
2300 - Newcastle
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
7001 - Hobart
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Estonia
State/province [1] 0 0
Tallinn
Country [2] 0 0
Estonia
State/province [2] 0 0
Tartu
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Bochum
Country [5] 0 0
Germany
State/province [5] 0 0
Bonn
Country [6] 0 0
Germany
State/province [6] 0 0
Freiburg
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Germany
State/province [8] 0 0
Kiel
Country [9] 0 0
Germany
State/province [9] 0 0
Mannheim
Country [10] 0 0
Latvia
State/province [10] 0 0
Riga
Country [11] 0 0
Lithuania
State/province [11] 0 0
Klaipeda
Country [12] 0 0
Lithuania
State/province [12] 0 0
Vilnius
Country [13] 0 0
Netherlands
State/province [13] 0 0
Rotterdam
Country [14] 0 0
South Africa
State/province [14] 0 0
Cape Town
Country [15] 0 0
South Africa
State/province [15] 0 0
Durban
Country [16] 0 0
South Africa
State/province [16] 0 0
Hatfield, Pretoria
Country [17] 0 0
South Africa
State/province [17] 0 0
Morningside, Johannesburg
Country [18] 0 0
South Africa
State/province [18] 0 0
Port Elizabeth
Country [19] 0 0
South Africa
State/province [19] 0 0
Pretoria
Country [20] 0 0
South Africa
State/province [20] 0 0
Westridge, Durban
Country [21] 0 0
Ukraine
State/province [21] 0 0
Dnipropetrovsk
Country [22] 0 0
Ukraine
State/province [22] 0 0
Kharkov
Country [23] 0 0
Ukraine
State/province [23] 0 0
Kiev
Country [24] 0 0
Ukraine
State/province [24] 0 0
Lviv
Country [25] 0 0
Ukraine
State/province [25] 0 0
Odessa
Country [26] 0 0
Ukraine
State/province [26] 0 0
Uzhgorod
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Birmingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Manchester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Glasgow
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Leeds
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ICON Clinical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00057616
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries