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Phase II Efficacy Study of AZD6244 in Colorectal Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00514761
Collaborator
(none)
64
Enrollment
3
Locations
2
Arms
22
Duration (Months)
21.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2006
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Xeloda

Drug: Capecitabine
oral tablet
Other Names:
  • Xeloda

    		•
    Experimental: 2

    AZD6244

    Drug: AZD6244
    oral vial
    Other Names:
  • ARRY-142886

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression event count [assessed after each visit]

    Secondary Outcome Measures

    1. safety and tolerability [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Goiania Brazil
    2 Research Site Rio de Janeiro Brazil
    3 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00514761
    Other Study ID Numbers:
    • D1532C00011
    First Posted:
    Aug 10, 2007
    Last Update Posted:
    Aug 13, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by AstraZeneca
    colorectal cancer
    AZD6244
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Capecitabine

    Study Results

    No Results Posted as of Aug 13, 2014