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A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients

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ClinicalTrials.gov Identifier: NCT04024696
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Xynomic Pharmaceuticals, Inc.

Brief Summary:
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: Abexinostat Phase 1 Phase 2

Detailed Description:

This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.

Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurance of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Dosing Cohorts
Three (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC).
Drug: Abexinostat
Abexinostat Tosylate Tablets




Primary Outcome Measures :
  1. Measure AUC at Different Dose Level [ Time Frame: Up to 6 month ]
    Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level

  2. Measure Cmax at Different Dose Level [ Time Frame: Up to 6 month ]
    Measure Peak Plasma Concentration (Cmax at different dose level

  3. Determine the maximum tolerated dose [ Time Frame: Up to 6 month ]
    Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels


Secondary Outcome Measures :
  1. Measure Objective Response Rate [ Time Frame: Up to 12 Month ]
    Measure objective response rate in % at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care

  2. Measure Duration of Response [ Time Frame: Up to 12 Month ]
    Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis o f non Hodgkin's lymphoma
  • Patients with non-Hodgkin's lymphoma who have either failed standard of care or are intolerant/unapplicable to therapy;
  • Subject who has no growth factor supportive therapy, transfusion of blood or blood products within 14 days before the enrollment test
  • The patient is capable and willing to accept the follow up according to the protocol and signed or provided the ICF signed by the legal representative
  • Contraceptive measures , definition of women of childbearing age and contraceptive requirements

Exclusion Criteria:

  • Subjects who have received anti tumor therapy and have not recovered from previous toxicity reactions ( toxicity reactions unrecovered to grade 1 as per NCI CTCAE 5.0
  • Subjects who received major surgery (excluding diagnostic biopsy)within 28 days prior to the first dose.
  • Subjects who received autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation within 6 months prior to the first dose with active graft versus host response at screening
  • Subjects with use of prohibited medication within 7 days or less than 5 half lives prior to the first dose (whichever is shorter), see prohibited medication list
  • Participated in other interventional clinical trial within 1 month or 5 half life periods prior to the first dose (whichever is longer), except for non intervention clinical trials
  • Evidence suggests that there may be human immunodeficiency virus (HIV) infection , or hepatitis C (HCV) hepatitis virus infection PCR RNA positive);
  • Uncontrolled systemic infection or infection requiring intravenous injection of antibiotics
  • Lymphoma with central nervous system (CNS) involvement
  • Subjects with concurrent other malignant tumors in addition to the studied tumor within 2 years prior to the first dosing , except for the controlled skin basal cell carcinoma , cervical carcinoma in situ, ductal carcinoma in situ , and papillary thyroid carcinoma
  • Subject is known to be allergic to the components of abexinostat
  • Pregnant and lactating subjects
  • Upon the investigator's judgment , the subject has any disease or medical condition that is unstable or may affect safety or study compliance , such as uncontrolled hypertension,uncontrolled diabetes, active bleeding , etc.

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): NCT04024696


Contacts
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Contact: Bing Zhao, MD (01186)13716386801 bzhao@xynomicpharma.com
Contact: Sophia Paspal, Ph.D sophia.paspal@xynomicpharma.com

Sponsors and Collaborators
Xynomic Pharmaceuticals, Inc.
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Yuankai Shi, M.D.; Prof Cancer Hospital Chinese Academy Of Medical Science

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Responsible Party: Xynomic Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04024696     History of Changes
Other Study ID Numbers: XYN-609
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abexinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action