Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
NCT01584830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2016-02-08
Summary
The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.
Conditions
- Colorectal Neoplasms
Interventions
- DRUG
-
Regorafenib (BAY73-4506)
Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)
- DRUG
-
Placebo will be given 3 weeks on/1 week off (160 mg od po.)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2013-11-30
- Completion
- 2016-01-31
Countries
- China
- Hong Kong
- South Korea
- Taiwan
- Vietnam
Study Locations
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