Phase II Efficacy Study of AZD6244 in Colorectal Cancer
- Registration Number
- NCT00514761
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 AZD6244 AZD6244 1 Capecitabine Xeloda
- Primary Outcome Measures
Name Time Method Progression event count assessed after each visit
- Secondary Outcome Measures
Name Time Method safety and tolerability assessed at each visit
Trial Locations
- Locations (1)
Research Site
🇧🇷Sao Paulo, Brazil