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A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b

NCT02279433 ↗

Phase 1 Completed 46 enrolled Nuvation Bio Inc. AnHeart Therapeutics Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.

Timeline

Start
2014-09
Primary completion
2019-03
Completion
2019-03

Drugs

EvaluationDrugModalityDoseRoute
Subject DS-6051b Unknown 50 mg Oral
Subject DS-6051b Unknown 200 mg Oral

Indications

cancer