Phase II Efficacy Study of AZD6244 in Colorectal Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Capecitabine; Drug: AZD6244

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514761

D1532C00011

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

1

Active Comparator group

Description:

Xeloda

Treatment:

Drug: Capecitabine

2

Experimental group

Description:

AZD6244

Treatment:

Drug: AZD6244