Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1/2 Study of CG200745 PPA for Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737462
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

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 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.

<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. 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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: CG200745 PPA Phase 1 Phase 2

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 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. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CG200745 PPA
CG200745 PPA intravenously daily for first 5 consecutive days per cycle (4 weeks)
Drug: CG200745 PPA
CG200745 PPA intravenously daily for first 5 consecutive days per cycle (4 weeks)
Other Name: CG200745 PPA (phosphoric acid)




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: up to 6 cycles (each cycle is 28 days) ]
    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


Secondary Outcome Measures :
  1. Area Under the Curve [AUC] [ Time Frame: Part I, Cycle 1, Day 1, up to 6 days ]
    Pharmacokinetics (PK) parameter

  2. Maximum Plasma Concentration [Cmax] [ Time Frame: Part I, Cycle 1, Day 1, up to 6 days ]
    Pharmacokinetics (PK) parameter

  3. Adverse Event [ Time Frame: up to 6 cycles ]
    Safety parameter

  4. Clinical laboratory tests [ Time Frame: up to 6 cycles ]
    Safety parameter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737462


Contacts
Layout table for location contacts
Contact: Sangsook Cho, Ph.D. +1 925 876 1975 scho@cgxinc.com
Contact: Chohee Park +82 31 628 2872 chpark@cgxinc.com

Locations
Layout table for location information
Korea, Republic of
Asan Medical Center, Samsung Medical Center, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sujeong Kim, R.N.         
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT02737462     History of Changes
Other Study ID Numbers: CG200745-2-02
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms