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Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

NCT03055286 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-26

No results posted yet for this study

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 \[PR\]).

Conditions

Interventions

DRUG

CWP232291

For cohort 1-3, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 5 following CWP232291 infusion. For cohort 4, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 7 following 250 mg/m2 CWP232291 infusion.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2025-08-26
Completion
2025-08-26
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055286 on ClinicalTrials.gov