Phase II Efficacy Study of AZD6244 in Colorectal Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Capecitabine

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