Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The phase I clinical trial is to identify the MTD (Maximum Tolerated
Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA. Initial dose of CG200745 PPA is 150
mg/m^2, and it will be extended to 225 mg/m^2, 300 mg/m^2 or it will be reduced to 75 mg/m^2
based on the results of the cohort of 3 subjects per dose level.
Based on the 3+3 dose escalation study design, CG200745 PPA is to be administered as in four
different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects.
In the phase II clinical trial, the subjects will be administered
with the dose which is to be identified as a recommended dose based on the results of Phase I
study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment
period is 6 cycles and tumor assessment is evaluated every 2 cycles.