drugset / Trial / NCT02308553
Efficacy and Safety of Nintedanib Combined With Paclitaxel Chemotherapy for Patients With BRAF wt Metastatic Melanoma
Phase 1/2
Completed
33 enrolled
Prof. Dr. med. Dirk Schadendorf
Alcedis GmbH · collabBoehringer Ingelheim · collabmedac GmbH · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial designed to characterize the safety and estimate the efficacy of nintedanib when combined with paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with BRAF wild type metastatic melanoma not previously treated with taxanes or kinase inhibitors.
Timeline
- Start
- 2015-03-17
- Primary completion
- 2019-10-17
- Completion
- 2019-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 150 mg | — |
| Subject | Nintedanib | Small molecule | 200 mg | — |
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | — |