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Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

NCT02737462 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-09-13

No results posted yet for this study

Summary

\<Part I - Phase I trial\> 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 to 6 subjects per dose level.

Based on the 3+3 dose escalation study design, CG200745 PPA is to be administered according to the dose level. Each cohort consists of 3 or 6 subjects.

\<Part II - Phase II trial\> 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. Each cycle consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles and tumor assessment is to be evaluated at the end of every 2 cycles.

Conditions

Interventions

DRUG

CG200745 PPA

CG200745 PPA intravenously daily for first 5 consecutive days per cycle (4 weeks)

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Je-Hwan Lee, M.D., PhD. · Asan Medical Center

  • Jun Ho Jang, M,D., Ph.D. · Samsung Medical Center

  • Sung-soo Yoon, M,D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT02737462 on ClinicalTrials.gov