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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
EUDRACT No. 2006-001456-12
Secondary ID [2] 0 0
D1532C00003
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 - AZD6244
Treatment: Drugs - Temozolomide

Active comparator: 1 - Temozolomide

Experimental: 2 - AZD6244


Treatment: Drugs: AZD6244
Oral liquid or Capsule

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

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Primary outcome [2] 0 0
Time to death
Timepoint [2] 0 0
From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Primary outcome [3] 0 0
Objective Response Rate
Timepoint [3] 0 0
RECIST data collected as per institutional standard practise
Primary outcome [4] 0 0
Duration of response
Timepoint [4] 0 0
RECIST data collected as per institutional standard practise
Secondary outcome [1] 0 0
Assessment of the safety and tolerability of AZD6244
Timepoint [1] 0 0
Assessed at all visits
Secondary outcome [2] 0 0
Investigation of the pharmacokinetics of AZD6244
Timepoint [2] 0 0
Day 1 & 8 (for patients on AZD6244)
Secondary outcome [3] 0 0
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
Timepoint [3] 0 0
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

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

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 2
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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment hospital [3] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad de Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Vicente Lopez
Country [12] 0 0
Austria
State/province [12] 0 0
St. Pölten
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Brazil
State/province [14] 0 0
Belo Horizonte
Country [15] 0 0
Brazil
State/province [15] 0 0
Curitiba
Country [16] 0 0
Brazil
State/province [16] 0 0
Goiânia
Country [17] 0 0
Brazil
State/province [17] 0 0
Porto Alegre
Country [18] 0 0
Brazil
State/province [18] 0 0
Salvador
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
State/province [22] 0 0
Odense
Country [23] 0 0
France
State/province [23] 0 0
Boulogne Billancourt
Country [24] 0 0
France
State/province [24] 0 0
Nantes Cedex 1
Country [25] 0 0
France
State/province [25] 0 0
Villejuif Cedex
Country [26] 0 0
Switzerland
State/province [26] 0 0
Zürich
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Glasgow
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Oxford

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
AZD6244 Medical Science Director, MD
Address 0 0
AstraZeneca
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/NCT00338130