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Brief Title: Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients
Official Title: A Phase 1b/2a Clinical Study of CWP232291 in Combination With Cytarabine in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT03055286
Brief 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 \[PR\]).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Washington, Seattle, Washington, United States
Samsung medical center, Seoul, Gangnam-gu, Korea, Republic of
Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of
Asan Medical Center, Seoul, Songpa-Gu, Korea, Republic of