Phase II efficacy study of AZD6244 in colorectal cancer
Study identifier:D1532C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Metastatic Colorectal Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD6244, Capecitabine
Sex
All
Actual Enrollment
64
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: 01 Jun 2007
Study Completion Date: 01 Jul 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Clive Morris
AstraZeneca
