Phase II Efficacy Study of AZD6244 in Colorectal Cancer

A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00514761

Enrollment

Registered

2007-08-10

Start date

2006-09-30

Completion date

2008-07-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer, AZD6244

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.

Interventions

DRUGAZD6244

oral vial

DRUGCapecitabine

oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Progression event count	assessed after each visit

Secondary

Measure	Time frame
safety and tolerability	assessed at each visit

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026