drugset / Trial / NCT02345382

Phase I Dose Escalation of BAY1143572 in Subjects With Acute Leukemia

NCT02345382 ↗

Phase 1 Completed 42 enrolled Bayer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule in subjects with advanced acute leukemia

Timeline

Start
2015-02-19
Primary completion
2016-09-14
Completion
2017-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atuveciclib Small molecule 20 mg Oral
Subject Atuveciclib Small molecule 40 mg Oral
Subject Atuveciclib Small molecule 80 mg Oral
Subject Atuveciclib Small molecule 120 mg Oral
Subject Atuveciclib Small molecule 160 mg Oral
Subject Atuveciclib Small molecule 200 mg Oral
Subject Atuveciclib Small molecule 240 mg Oral

Indications