Condition or disease | Intervention/treatment | Phase |
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Non Hodgkin Lymphoma | Drug: Abexinostat | Phase 1 Phase 2 |
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 occurrence 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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
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 |
Actual Study Start Date : | January 8, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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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).
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Drug: Abexinostat
Abexinostat Tosylate Tablets
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bing Zhao, MD | (01186)13716386801 | bzhao@xynomicpharma.com | |
Contact: Sophia Paspal, Ph.D | sophia.paspal@xynomicpharma.com |
China | |
Cancer Hospital Chinese Academy of Medical Sciences | Recruiting |
Beijing, China, 100021 | |
Contact: Shi Yuankai, MD, PhD 13701251865 syuankaipumc@126.com | |
Principal Investigator: Shao Zonghong, MD | |
Zhejiang Cancer Hospital | Recruiting |
Hangzhou, China, 310022 | |
Contact: Yang Haiyan, MD, PhD 13857182590 haiyanyang1125@163.com | |
Tianjin Medical University General Hospital | Recruiting |
Tianjin, China, 300052 | |
Contact: Shao Zonghong, MD 13802036467 shaozonghong@sina.com | |
The Affiliated Hospital of Xuzhou Medical University | Recruiting |
Xuzhou, China, 221006 | |
Contact: Li Zhenyu, MD 13852439312 frankfeng_2004@126.com |
Principal Investigator: | Yuankai Shi, M.D.; Prof | Cancer Hospital Chinese Academy Of Medical Science |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 9, 2019 | ||||||||
First Posted Date ICMJE | July 18, 2019 | ||||||||
Last Update Posted Date | May 12, 2021 | ||||||||
Actual Study Start Date ICMJE | January 8, 2020 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients | ||||||||
Official Title ICMJE | 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 | ||||||||
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. | ||||||||
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 occurrence 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 ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A 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 |
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Condition ICMJE | Non Hodgkin Lymphoma | ||||||||
Intervention ICMJE | Drug: Abexinostat
Abexinostat Tosylate Tablets
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Study Arms ICMJE | 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).
Intervention: Drug: Abexinostat
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
25 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04024696 | ||||||||
Other Study ID Numbers ICMJE | XYN-609 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xynomic Pharmaceuticals, Inc. | ||||||||
Study Sponsor ICMJE | Xynomic Pharmaceuticals, Inc. | ||||||||
Collaborators ICMJE | Chinese Academy of Medical Sciences | ||||||||
Investigators ICMJE |
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PRS Account | Xynomic Pharmaceuticals, Inc. | ||||||||
Verification Date | May 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |