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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with
temozolomide in patients with advanced melanoma
Trial website
https://clinicaltrials.gov/show/NCT00338130
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

Summary results
Other publications