Trials / Completed
CompletedNCT03564938
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regorafenib (Stivarga, BAY73-4506) | The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy). |
Timeline
- Start date
- 2018-07-30
- Primary completion
- 2023-03-20
- Completion
- 2023-12-01
- First posted
- 2018-06-21
- Last updated
- 2024-12-03
Locations
13 sites across 1 country: India
Source: ClinicalTrials.gov record NCT03564938. Inclusion in this directory is not an endorsement.