Phase II Efficacy Study of AZD6244 in Colorectal Cancer

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: AZD6244; Drug: Capecitabine

• 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

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-06
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-10
• Study Completion: 2008-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

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