drugset / Trial / NCT02522910

An Open-label Phase Ib/II Study of BAY 1000394 (Roniciclib) in Combination With Docetaxel in Second- or Third-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT02522910

Phase 1/2 Withdrawn Yonsei University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.

Timeline

Start
2015-08
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Roniciclib Small molecule
Background Docetaxel Small molecule