drugset / Trial / NCT00876460
BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
Timeline
- Start
- 2009-03
- Primary completion
- 2012-09
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Nintedanib | Small molecule | 200 mg | Oral |