Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

NCT ID: NCT02737462

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CG200745 PPA

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

Group Type: EXPERIMENTAL

CG200745 PPA

Intervention Type: DRUG

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

Interventions

CG200745 PPA

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

Intervention Type: DRUG

Other Intervention Names

CG200745 PPA (phosphoric acid)

Eligibility Criteria

Inclusion Criteria

• Ages: 20 years and above
• Patient with MDS according to French-American-British (FAB) classification
• Patients who failed to respond to prior hypomethylating agents (5-azacytidine, decitabine)
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
• Adequate renal and hepatic function

• Total serum bilirubin ≤ 3 x Upper Limit Normal (ULN) (except for the case of increased unconjugated bilirubin)
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline phosphatase (ALP) < 3 x ULN
• Calculated Glomerular Filtration Rate (GFR) ≥ 50
• Fertile patients, except post-menopausal patients (no menstruation for at least 2 years) or proof of surgical sterility, must use effective contraception up to 3 months after the completion or withdrawal of the study.
• Negative pregnancy test
• Patients who understand the overall procedures and requirements of the study

Exclusion Criteria

• Peripheral or bone marrow blasts: > 30%
• Less than 4 weeks since major surgery or radiotherapy
• Patient with clinically meaningful and relevant, active Central Nerve System (CNS) disorder
• Patient with active liver disease
• Patient with HIV positive
• Hyper-sensitivity to study drug or similar substances of the drugs
• Prior Histone Deacetylase (HDAC) inhibitor therapy
• Less than 4 weeks since hypomethylating agent or cytotoxic drug therapy
• Less than 4 weeks since immunosuppressive drug therapy
• Patient who participated in another clinical trial within past 4 weeks
• Patient who have severe diseases:

• Severe cardiovascular diseases (severe or unstable angina, congestive heart failure, myocardial infarction within past 1 year, uncontrolled hypertension and uncontrolled arrhythmia)
• Neurological or psychiatric disorder
• Active uncontrolled infection
• Any other diseases that may interfere with the interpretation of study result (according to the judgment of investigator)
• Pregnancy or lactating
• Patient who is not considered to be appropriate for the study according to the judgment of investigator

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CrystalGenomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Je-Hwan Lee, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Jun Ho Jang, M,D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Sung-soo Yoon, M,D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Asan Medical Center, Samsung Medical Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CG200745-2-02

Identifier Type: -

Identifier Source: org_study_id