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Phase II Efficacy Study of AZD6244 in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00514761
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: AZD6244 Drug: Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2006
Primary Completion Date : June 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: Capecitabine
oral tablet
Other Name: Xeloda
Experimental: 2
Drug: AZD6244
oral vial
Other Name: ARRY-142886

Primary Outcome Measures :
  1. Progression event count [ Time Frame: assessed after each visit ]

Secondary Outcome Measures :
  1. safety and tolerability [ Time Frame: assessed at each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514761

Research Site
Goiania, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Clive Morris, MD AstraZeneca
Study Director: Gill Pover, MD AstraZeneca
Study Director: Lance Smith AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00514761     History of Changes
Other Study ID Numbers: D1532C00011
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by AstraZeneca:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents