drugset
drugset / Trial / NCT02891590

Safety, Tolerability and PK of BTK Inhibitor DTRMWXHS-12 in Patients With B-Cell Lymphomas

NCT02891590 ↗

Phase 1 Completed 13 enrolled Zhejiang DTRM Biopharma
NaSingle-groupOpen-labelTreatment

Summary

The Primary Objective is to evaluate the safety and tolerability of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma. The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.

Timeline

Start
2016-09
Primary completion
2019-02
Completion
2019-02

Drugs

EvaluationDrugModalityDoseRoute
Subject DTRMWXHS-12 Unknown 50 mg Oral
Subject DTRMWXHS-12 Unknown 100 mg Oral
Subject DTRMWXHS-12 Unknown 200 mg Oral
Subject DTRMWXHS-12 Unknown 400 mg Oral
Subject DTRMWXHS-12 Unknown 600 mg Oral
Subject DTRMWXHS-12 Unknown 800 mg Oral

Indications

B-cell chronic lymphocytic leukemia