Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01362361 | 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) | PHASE2 | COMPLETED | 54 | — | — | Jun 1, 2011 | Dec 1, 2016 | Sep 19, 2019 | 12 | Germany |
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | mFOLFOX6 + BIBF 1120 |
| Arm B | PLACEBO_COMPARATOR | mFOLFOX6+placebo |
| Name | Type | Description |
|---|---|---|
| mFOLFOX6 + BIBF 1120 | DRUG | mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days) |
| mFOLFOX6+placebo | DRUG | mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days) |
Inclusion Criteria: 1. Histologically proven colorectal adenocarcinoma 2. Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for metastatic CRC 3. Age \> 18 years 4. Metastatic disease not suitable for curative-intent surgery 5. Measurable (\> 1 cm) and evaluable disease (acco...