Phase II Efficacy Study of AZD6244 in Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00514761
First received: August 9, 2007
Last updated: May 13, 2009
Last verified: May 2009

August 9, 2007
May 13, 2009
September 2006
June 2007   (final data collection date for primary outcome measure)
Progression event count [ Time Frame: assessed after each visit ] [ Designated as safety issue: Yes ]
Progression event count
Complete list of historical versions of study NCT00514761 on ClinicalTrials.gov Archive Site
safety and tolerability [ Time Frame: assessed at each visit ] [ Designated as safety issue: Yes ]
safety and tolerability
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: AZD6244
    oral vial
    Other Name: ARRY-142886
  • Drug: Capecitabine
    oral tablet
    Other Name: Xeloda
  • Active Comparator: 1
    Xeloda
    Intervention: Drug: Capecitabine
  • Experimental: 2
    AZD6244
    Intervention: Drug: AZD6244
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2008
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00514761
D1532C00011
No
Not Provided
AstraZeneca
Not Provided
Study Director: Clive Morris, MD AstraZeneca
Study Director: Gill Pover, MD AstraZeneca
Study Director: Lance Smith AstraZeneca
AstraZeneca
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP