drugset / Trial / NCT01525602

Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

NCT01525602

Phase 1 Completed 74 enrolled Daiichi Sankyo Plexxikon · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Timeline

Start
2012-05
Primary completion
2017-12
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexidartinib Small molecule 200 mg Oral
Background Paclitaxel Small molecule Intravenous

Indications