A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-Label Phase I Part to Assess the Safety and Tolerability of AZD2171 in Combination With FOLFOX Followed by a Phase II, Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy of AZD2171 in Combination With FOLFOX
Phase 1
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- JPRN-jRCT2080220420
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 18 Years and above
Genders Eligible for Study: Both
Inclusion Criteria:
- Metastatic colorectal cancer
- WHO performance status 0-1
- Life expectancy is 12 weeks or longer
Exclusion Criteria
- Patient with uncontrolled brain metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Primary Outcome Measures:- Progression of Metastatic Colorectal Cancer (mCRC) - PFS Secondary Outcome Measures: - Safety and tolerability [Time Frame: assessed at each visit]
- Secondary Outcome Measures
Name Time Method