Phase II Efficacy Study of AZD6244 in Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
AZD6244
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring colorectal cancer, AZD6244
Eligibility Criteria
Inclusion Criteria:
- colorectal cancer
- require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
- have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks
Exclusion Criteria:
- previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
- any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
- nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Xeloda
AZD6244
Outcomes
Primary Outcome Measures
Progression event count
Secondary Outcome Measures
safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00514761
Brief Title
Phase II Efficacy Study of AZD6244 in Colorectal Cancer
Official Title
A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal cancer, AZD6244
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Xeloda
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 vial
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Progression event count
Time Frame
assessed after each visit
Secondary Outcome Measure Information:
Title
safety and tolerability
Time Frame
assessed at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
colorectal cancer
require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks
Exclusion Criteria:
previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Morris, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gill Pover, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lance Smith
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Goiania
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1172&filename=CSR-D1532C00011.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1172&filename=CSR-D1532C00011.pdf
Description
CSR-D1532C00011.pdf
Learn more about this trial
Phase II Efficacy Study of AZD6244 in Colorectal Cancer
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