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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Secondary ID [1] 0 0
A3671009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
overall survival
Timepoint [1] 0 0
August 2010
Secondary outcome [1] 0 0
adverse events
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
PFS at 6 months
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
objective tumor response
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Durable response
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
pharmacokinetics endpoints
Timepoint [5] 0 0
15 months
Secondary outcome [6] 0 0
pharmacogenomic endpoints
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
HQol
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
healthcare resource utilization and loss of productivity
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
human antihuman antibody response for patients in Arm A
Timepoint [9] 0 0
15 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
655
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment hospital [4] 0 0
Research Site - Adelaide
Recruitment hospital [5] 0 0
Research Site - Launceston
Recruitment hospital [6] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2300 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
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United States of America
State/province [4] 0 0
California
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United States of America
State/province [5] 0 0
Colorado
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United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
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Florida
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United States of America
State/province [8] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Maryland
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Leuven
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Belgium
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Namur
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Belgium
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Roeselare
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Belgium
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Turnhout
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Belgium
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Wilrijk
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Belgium
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Yvoir
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Cedex 05
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France
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Besancon
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France
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Bordeaux
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France
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Boulogne
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France
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Caen
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France
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Lille
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France
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Marseille
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France
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Nantes Cedex 1
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Tuebingen
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Greece
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Athens
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Siena
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Mexico
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DF
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Netherlands
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GR
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NH
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ZH
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Netherlands
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Nijmegen
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Poland
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Bialystok
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Poland
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Krakow
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Lubin
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Poznan
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Poland
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Warszawa
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Russian Federation
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Kaluga Region
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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South Africa
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Cape Town
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South Africa
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Pretoria
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Zaragoza
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Sweden
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Goteborg
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Sweden
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Lund
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Switzerland
State/province [85] 0 0
Zurich
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cornwall
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United Kingdom
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Middlesex
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United Kingdom
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Surrey
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Newcastle Upon Tyne
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00257205