drugset / Trial / NCT01616199
Study of PX-866 and Vemurafenib in Patients With Advanced Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the phase 1 portion of the study is to determine the maximally tolerated dose (MTD) or recommended dose (RD) and the safety/tolerability of PX-866 in combination vemurafenib in patients with any advanced BRAF-mutant cancer. The purpose of the phase 2 portion of the study is to compare progression free survival (PFS), antitumor activity (response rate), disease control rate (DCR), and the safety and tolerability of PX-866 in combination with vemurafenib vs. vemurafenib alone in patients with advanced BRAF-mutant melanoma at the doses recommended from Phase 1.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-12
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SONOLISIB | Small molecule | — | Oral |
| Subject | Vemurafenib | Small molecule | — | Oral |
Indications
No indication recorded.