Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory AML
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|ClinicalTrials.gov Identifier: NCT04501120|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : October 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Acute Myeloid Leukaemia||Drug: APG-2575 Drug: reduced-dose HHT Drug: standard-dose HHT Drug: Azacitidine||Phase 1 Phase 2|
This is an open-label, multi-center Phase Ib study of safety, PK of APG-2575 as a single agent or in combination with HHT or AZA in relapsed/refractory AML patients.
This study consists of three stages: The first stage is the APG-2575 single agent escalation study. The second stage is the APG-2575 combined with HHT/AZA escalation study. The third stage is the MTD/RP2D expansion cohort study of the combination regimen.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of the Safety, Pharmacokinetic of APG-2575 Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML|
|Actual Study Start Date :||September 28, 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: APG2575 single agent
APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg, to determine the MTD/RP2D.
APG-2575 orally once daily, every 28 days as a cycle.
Experimental: APG2575+ reduced-dose HHT
APG-2575 MTD/RP2D-1 and MTD/RP2D combines with reduced-dose HHT.
Drug: reduced-dose HHT
1mg IV QD on Days 1-14 (28-day cycle).
Experimental: APG2575+ standard-dose HHT
APG-2575 MTD/RP2D-1 and MTD/RP2D combines with standard-dose HHT.
Drug: standard-dose HHT
2mg/m^2 IV QD on Days 1-7 (28-day cycle).
Experimental: APG2575+ AZA
APG-2575 MTD/RP2D-1 and MTD/RP2D combines with AZA.
75 mg/m^2 SC QD on Days 1- 7 (28-day cycle).
- Dose Limiting Toxicities (DLT) [ Time Frame: 28 days ]DLT will be graded according to NCI CTCAE Version 5.0. DLT will be defined as clinically significant drug-related adverse events during the cycle one.
- Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose(RP2D) [ Time Frame: 28 days ]MTD/RP2D will be determined based on DLTs observed during cycle one.
- Maximum plasma concentration (Cmax) [ Time Frame: 28 days ]Cmax of APG-2575 will be assessed in the patients in single agent or combo study.
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 28 days ]AUC of APG-2575 will be assessed in the patients in single agent or combo study.
- Objective Response Rate (ORR) [ Time Frame: Up to 6 cycles (each cycle is 28 days). ]ORR is defined by CR+ CRi + PR(according to IWG AML(2003)).Response will be evaluated on cycle 1 and every even cycles till completing 6 cycles treatment or end of treatment.
- progression free survival (PFS) [ Time Frame: Up to 2 years. ]From date of treatment start until the date of progression or the date of death due to any cause.
- duration of response (DOR) [ Time Frame: Up to 2 years. ]From date of response until the date of progression.
- overall survival (OS) [ Time Frame: Up to 2 years. ]From date of treatment start until the date of death due to any cause.
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): NCT04501120
|Contact: Jie Jin, M.D.||+86 email@example.com|
|Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Qiang Jiang, Professor|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guandong, China|
|Contact: Yang Liang, Professor|
|Henan Tumor Hospital||Recruiting|
|Zhengzhou, Henan, China|
|Contact: Xudong Wei, Professor|
|Union Hospital medical college Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430022|
|Contact: Qiubo Li, Professor|
|Zhongnan Hospital of Hunan university||Recruiting|
|Wuhan, Hubei, China, 430071|
|Contact: Fuling Zhou, Professor|
|Contact: Jianying Zhou, Professor|
|Xiangya Hospital Central South University||Recruiting|
|Changsha, Hunan, China|
|Contact: Yajing Xu, Master|
|Contact: Qun He, Master|
|the First Affiliated Hospital, College of Medicine, Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Jie Jin, M.D. +86 571-87236896 firstname.lastname@example.org|
|Study Director:||Yifan Zhai, M.D., Ph.D.||Suzhou Yasheng Pharmaceutical Co., Ltd.|