Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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. Phase: Phase 1/Phase 2Accepts Healthy Volunteers? No

Details

• Lead Sponsor: CrystalGenomics, Inc.

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

• Modification of Diet in Renal Disease (MDRD)-GFR (mL/min/1.73m2) (for female): 186 x (serum creatinine concentration)-1.154 x (age)-0.203 x 0.742 (for female)

• 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

• Patient 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