drugset / Trial / NCT01930292
Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
Timeline
- Start
- 2013-04
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xevinapant | Small molecule | 50 mg | Oral |
| Subject | Xevinapant | Small molecule | 400 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |