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.
1 other identifier
interventional
64
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedAugust 13, 2014
August 1, 2014
9 months
August 9, 2007
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression event count
assessed after each visit
Secondary Outcomes (1)
safety and tolerability
assessed at each visit
Study Arms (2)
1
ACTIVE COMPARATORXeloda
2
EXPERIMENTALAZD6244
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Goiânia, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
São Paulo, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clive Morris, MD
AstraZeneca
- STUDY DIRECTOR
Gill Pover, MD
AstraZeneca
- STUDY DIRECTOR
Lance Smith
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
September 1, 2006
Primary Completion
June 1, 2007
Study Completion
July 1, 2008
Last Updated
August 13, 2014
Record last verified: 2014-08