Phase II Efficacy Study of AZD6244 in Colorectal Cancer

AstraZeneca64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

AZD6244DRUG

oral vial

CapecitabineDRUG

oral tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Goiânia, Brazil

Research Site

Rio de Janeiro, Brazil

Research Site

São Paulo, Brazil

Outcomes

Primary Outcomes

Progression event count

Time frame: assessed after each visit

Secondary Outcomes

safety and tolerability

Time frame: assessed at each visit

Data from ClinicalTrials.gov

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