Phase II Efficacy Study of AZD6244 in Colorectal Cancer

NCT ID: NCT00514761

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Xeloda

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

oral tablet

2

AZD6244

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

oral vial

Interventions

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AZD6244

oral vial

Intervention Type DRUG

Capecitabine

oral tablet

Intervention Type DRUG

Other Intervention Names

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ARRY-142886 Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clive Morris, MD

Role: STUDY_DIRECTOR

AstraZeneca

Gill Pover, MD

Role: STUDY_DIRECTOR

AstraZeneca

Lance Smith

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Goiânia, , Brazil

Site Status

Research Site

Rio de Janeiro, , Brazil

Site Status

Research Site

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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D1532C00011

Identifier Type: -

Identifier Source: org_study_id

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