drugset / Trial / NCT02138812

Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel

NCT02138812 ↗

Phase 1 Terminated 69 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced malignancies.

Timeline

Start
2014-05-09
Primary completion
2017-04-28
Completion
2017-10-02

Outcome

Outcome not reported

Stopped (Business): “As another Mps1 inhibitor was being developed in parallel, the strategic decision was to move forward with the development of the follow up compound only.”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY1161909 Small molecule 0.75 mg —
Subject BAY1161909 Small molecule 6 mg —
Subject Paclitaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 90 mg/m2 Intravenous

Indications

No indication recorded.