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Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD6244
Temozolomide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Phase II, AZD6244, temozolomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Temozolomide

AZD6244

Outcomes

Primary Outcome Measures

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)
Time to death
Objective Response Rate
Duration of response

Secondary Outcome Measures

Assessment of the safety and tolerability of AZD6244
Investigation of the pharmacokinetics of AZD6244
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive

Full Information

First Posted
June 15, 2006
Last Updated
August 12, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00338130
Brief Title
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Phase II, AZD6244, temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Temozolomide
Arm Title
2
Arm Type
Experimental
Arm Description
AZD6244
Intervention Type
Drug
Intervention Name(s)
AZD6244
Other Intervention Name(s)
ARRY-142886
Intervention Description
Oral liquid or Capsule
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
oral
Primary Outcome Measure Information:
Title
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)
Time Frame
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Title
Time to death
Time Frame
From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Title
Objective Response Rate
Time Frame
RECIST data collected as per institutional standard practise
Title
Duration of response
Time Frame
RECIST data collected as per institutional standard practise
Secondary Outcome Measure Information:
Title
Assessment of the safety and tolerability of AZD6244
Time Frame
Assessed at all visits
Title
Investigation of the pharmacokinetics of AZD6244
Time Frame
Day 1 & 8 (for patients on AZD6244)
Title
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive
Time Frame
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AZD6244 Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Miami Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Niles
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Vicente Lopez
Country
Argentina
Facility Name
Research Site
City
Heidelberg
Country
Australia
Facility Name
Research Site
City
Nedlands
Country
Australia
Facility Name
Research Site
City
Waratah
Country
Australia
Facility Name
Research Site
City
St. Pölten
Country
Austria
Facility Name
Research Site
City
Wien
Country
Austria
Facility Name
Research Site
City
Belo Horizonte
Country
Brazil
Facility Name
Research Site
City
Curitiba
Country
Brazil
Facility Name
Research Site
City
Goiânia
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Salvador
Country
Brazil
Facility Name
Research Site
City
São Paulo
Country
Brazil
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Boulogne Billancourt
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
Country
France
Facility Name
Research Site
City
Villejuif Cedex
Country
France
Facility Name
Research Site
City
Zürich
Country
Switzerland
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1530&filename=CSR-1839IL-0151.pdf
Description
CSR-1839IL-0151.pdf

Learn more about this trial

Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

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