Trials / Completed
CompletedNCT01362361
TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)
TRICC-C: A Multicenter, Randomized, Phase II Trial: BIBF 1120 vs. Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study: To explore the comparative effectiveness of BIBF 1120 in terms of : * Progression-free survival (PFS), objective response, overall survival * Evaluate and compare safety
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mFOLFOX6 + BIBF 1120 | mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days) |
| DRUG | mFOLFOX6+placebo | mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days) |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2016-06-01
- Completion
- 2016-12-01
- First posted
- 2011-05-30
- Last updated
- 2019-09-19
Locations
12 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01362361. Inclusion in this directory is not an endorsement.