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Trial registered on ANZCTR


Trial ID
ACTRN12606000010594
Ethics application status
Approved
Date submitted
4/01/2006
Date registered
4/01/2006
Date last updated
4/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016)
Scientific title
Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016) in Patients with Unresectable Stage III or IV Malignant Melanoma
Universal Trial Number (UTN)
Trial acronym
CA184-004
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Stage III or IV Malignant Melanoma 971 0
Condition category
Condition code
Cancer 1045 1045 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose Comparison of MDX-010 (BMS-734016). Treatment up to week 10 and beyond depending upon response.
Intervention code [1] 822 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1399 0
To identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS-734016).
Timepoint [1] 1399 0
Tumour response measured starting at week 12 through week 24. Those continuing on therapy after week 24 have tumour responses evaluated every 3 months.
Secondary outcome [1] 2469 0
Safety & tumour response.
Timepoint [1] 2469 0
Safety evaluated on a continuous and ongoing basis.

Eligibility
Key inclusion criteria
Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma). A pre- and post-treatment fresh core or excision tumour biopsy must be provided.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation to numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Interactive voice response system (IVRS) to assign patient to dose group based on randomisation schedule computer generated and maintained by sponsor. Randomisation using a permuted block procedure and stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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

Funding & Sponsors
Funding source category [1] 1143 0
Commercial sector/Industry
Name [1] 1143 0
Bristol-Myers Squibb Pty Ltd
Address [1] 1143 0
Country [1] 1143 0
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Pty Ltd.
Address
Country
United States of America
Secondary sponsor category [1] 1000 0
None
Name [1] 1000 0
None
Address [1] 1000 0
Country [1] 1000 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35420 0
Address 35420 0
Country 35420 0
Phone 35420 0
Fax 35420 0
Email 35420 0
Contact person for public queries
Name 10011 0
Mr Richard Wykes
Address 10011 0
Department of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 10011 0
Australia
Phone 10011 0
+61 2 95156902
Fax 10011 0
+61 2 95155063
Email 10011 0
richard.wykes@email.cs.nsw.gov.au
Contact person for scientific queries
Name 939 0
Mr Richard Wykes
Address 939 0
Department of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 939 0
Australia
Phone 939 0
+61 2 95156902
Fax 939 0
+61 2 95155063
Email 939 0
richard.wykes@email.cs.nsw.gov.au