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Phase II Efficacy Study of AZD6244 in Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514761
First Posted: August 10, 2007
Last Update Posted: August 13, 2014
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Metastatic Colorectal Cancer Drug: AZD6244 Drug: Capecitabine Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 64
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Xeloda
Drug: Capecitabine
oral tablet
Other Name: Xeloda
Experimental: 2
AZD6244
Drug: AZD6244
oral vial
Other Name: ARRY-142886

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00514761     History of Changes
Other Study ID Numbers: D1532C00011
First Submitted: August 9, 2007
First Posted: August 10, 2007
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by AstraZeneca:
colorectal cancer
AZD6244

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