drugset / Trial / NCT03055286
Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CWP232291 | Small molecule | 250 mg/m2 | — |
| Background | Cytarabine | Small molecule | 1 g | Intravenous |