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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00257205
Registration number
NCT00257205
Ethics application status
Date submitted
18/11/2005
Date registered
22/11/2005
Date last updated
2/07/2012
Titles & IDs
Public title
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
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Scientific title
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
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Secondary ID [1]
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A3671009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dacarbazine
Treatment: Drugs - CP-675,206
Treatment: Drugs - temozolomide
Active Comparator: B - Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
Experimental: A -
Treatment: Drugs: dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12
Treatment: Drugs: CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4
Treatment: Drugs: temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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overall survival
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Assessment method [1]
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Timepoint [1]
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August 2010
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Secondary outcome [1]
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adverse events
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Timepoint [1]
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1 year
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Secondary outcome [2]
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PFS at 6 months
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Timepoint [2]
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6 months
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Secondary outcome [3]
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objective tumor response
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Assessment method [3]
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Durable response
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Timepoint [4]
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6 months
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Secondary outcome [5]
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pharmacokinetics endpoints
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Timepoint [5]
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15 months
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Secondary outcome [6]
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pharmacogenomic endpoints
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Timepoint [6]
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1 year
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Secondary outcome [7]
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HQol
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Timepoint [7]
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1 year
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Secondary outcome [8]
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healthcare resource utilization and loss of productivity
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Assessment method [8]
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Timepoint [8]
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1 year
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Secondary outcome [9]
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human antihuman antibody response for patients in Arm A
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Assessment method [9]
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Timepoint [9]
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15 months
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Eligibility
Key inclusion criteria
- Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional
lymph nodes and in-transit or satellite lesions.
- Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
- ECOG performance status of 0 or 1
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Received any systemic therapy for metastatic melanoma except post-surgical adjuvant
treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after
complete resection of melanoma.
- History of brain metastases
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2010
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Sample size
Target
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Accrual to date
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Final
655
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Research Site - Waratah
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Research Site - East Melbourne
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2300 - Waratah
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Recruitment postcode(s) [2]
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2145 - Westmead
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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7250 - Launceston
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Recruitment postcode(s) [6]
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3002 - East Melbourne
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with
surgically incurable metastatic melanoma who have received no prior chemotherapy, or
biochemotherapy for the treatment of metastatic disease. The primary objective of this trial
is to compare overall survival for patients with advanced melanoma who are randomized to
receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or
temozolomide (investigator choice)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00257205
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Contacts
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00257205
Download to PDF