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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/NCT00338130
Registration number
NCT00338130
Ethics application status
Date submitted
15/06/2006
Date registered
20/06/2006
Date last updated
13/08/2014
Titles & IDs
Public title
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ
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Scientific title
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma
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Secondary ID [1]
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EUDRACT No. 2006-001456-12
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Secondary ID [2]
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D1532C00003
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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 - AZD6244
Treatment: Drugs - Temozolomide
Active Comparator: 1 - Temozolomide
Experimental: 2 - AZD6244
Treatment: Drugs: AZD6244
Oral liquid or Capsule
Treatment: Drugs: Temozolomide
oral
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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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To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
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Assessment method [1]
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Timepoint [1]
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From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
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Primary outcome [2]
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Time to death
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Assessment method [2]
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Timepoint [2]
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From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
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Primary outcome [3]
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Objective Response Rate
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Assessment method [3]
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Timepoint [3]
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RECIST data collected as per institutional standard practise
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Primary outcome [4]
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Duration of response
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Assessment method [4]
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Timepoint [4]
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RECIST data collected as per institutional standard practise
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Secondary outcome [1]
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Assessment of the safety and tolerability of AZD6244
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Assessment method [1]
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Timepoint [1]
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Assessed at all visits
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Secondary outcome [2]
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Investigation of the pharmacokinetics of AZD6244
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Assessment method [2]
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Timepoint [2]
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Day 1 & 8 (for patients on AZD6244)
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Secondary outcome [3]
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Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
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Assessment method [3]
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Timepoint [3]
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From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
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Eligibility
Key inclusion criteria
- Diagnosed with late stage malignant melanoma
- Aged 18 or over
- Female patients must be post-menopausal or with negative urine pregnancy test if
pre-menopausal
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Minimum age
18
Years
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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
- Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
- Participation in any other trial with an investigational product within the previous
30 days
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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 2
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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
1/07/2006
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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
1/07/2013
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Sample size
Target
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Accrual to date
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Final
239
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Heidelberg
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Recruitment hospital [2]
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Research Site - Nedlands
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Recruitment hospital [3]
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Research Site - Waratah
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Recruitment postcode(s) [1]
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- Heidelberg
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Recruitment postcode(s) [2]
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- Nedlands
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Recruitment postcode(s) [3]
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- Waratah
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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New York
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Country [10]
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Argentina
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State/province [10]
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Ciudad de Buenos Aires
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Argentina
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Vicente Lopez
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Austria
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St. Pölten
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Austria
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Wien
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Brazil
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State/province [14]
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Belo Horizonte
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Brazil
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Curitiba
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Brazil
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Goiânia
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Brazil
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São Paulo
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Odense
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France
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Boulogne Billancourt
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France
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Nantes Cedex 1
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France
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Villejuif Cedex
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Switzerland
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Zürich
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United Kingdom
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Glasgow
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United Kingdom
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London
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Country [29]
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with
temozolomide in patients with advanced melanoma
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00338130
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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AZD6244 Medical Science Director, MD
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Address
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AstraZeneca
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00338130
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