NCT02737462

Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

A Phase I/II Study of CG200745 PPA to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy in Patients With Myelodysplastic Syndrome (MDS) Who Failed to Respond to Prior Hypomethylating Therapy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\<Part I - Phase I trial\> The phase I clinical trial is to identify the MTD and DLT 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 - 6 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. * Dose Level -1: CG200745 PPA 75 mg/m\^2 x 5 (375 mg/m\^2/cycle) / -50% * Dose Level 1: CG200745 PPA 150 mg/m\^2 x 5 (750 mg/m\^2/cycle) / initial base dose * Dose Level 2: CG200745 PPA 225 mg/m\^2 x 5 (1,125 mg/m\^2/cycle) / 50% * Dose Level 3: CG200745 PPA 300 mg/m\^2 x 5 (1,500 mg/m\^2/cycle) / 33% \<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

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	CG200745 PPA	CG200745 PPA intravenously daily for first 5 consecutive days per cycle (4 weeks)

Timeline

• Start date: 2016-06-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2016-04-14
• Last updated: 2023-09-13

Locations

1 site across 1 country: South Korea