drugset / Trial / NCT03055286

Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

NCT03055286

Phase 1/2 Terminated 15 enrolled JW Pharmaceutical
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C in subjects with relapsed or refractory AML. The primary objectives in phase 2a is to assess the efficacy of CWP232291 administered in combination with cytarabine (response rate complete remission \[RR-CR\]/complete remission with incomplete blood count recovery \[CRi\]/partial remission \[PR\]).

Timeline

Start
2017-02-06
Primary completion
2025-08-26
Completion
2025-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject CWP232291 Small molecule 250 mg/m2
Background Cytarabine Small molecule 1 g Intravenous