Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

NCT02737462 | Unknown Phase 1 DMC

• 1 other identifier: CG200745-2-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is the proportion of the subjects with Complete Response (CR), Partial Response (PR), marrow CR (mCR), and hematological improvement (HI) in comparison to the total subjects

  up to 6 cycles (each cycle is 28 days)

Secondary Outcomes (4)

• Area Under the Curve [AUC]

  Part I, Cycle 1, Day 1, up to 6 days

• Maximum Plasma Concentration [Cmax]

  Part I, Cycle 1, Day 1, up to 6 days

• Adverse Event

  up to 6 cycles

• Clinical laboratory tests

  up to 6 cycles

Study Arms (1)

CG200745 PPA

EXPERIMENTAL

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

Drug: CG200745 PPA

Interventions

CG200745 PPA DRUG

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

Also known as: CG200745 PPA (phosphoric acid)

CG200745 PPA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

phosphoric acid

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Je-Hwan Lee, M.D., PhD.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Jun Ho Jang, M,D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Sung-soo Yoon, M,D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 14, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

KR (1)