Phase II Efficacy Study of AZD6244 in Colorectal Cancer

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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

64 participants in 2 patient groups

1
Active Comparator group
Description:
Xeloda
Treatment:
Drug: Capecitabine
2
Experimental group
Description:
AZD6244
Treatment:
Drug: AZD6244

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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