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.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer
Both
Metastatic Colorectal Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression event count
Outcome Time Frame:
assessed after each visit
Safety Issue:
Yes
Principal Investigator
Clive Morris, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Sweden: Medical Products Agency
Study ID:
D1532C00011
NCT ID:
NCT00514761
Start Date:
September 2006
Completion Date:
July 2008
Related Keywords:
- Metastatic Colorectal Cancer
- colorectal cancer
- AZD6244
- Colorectal Neoplasms
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