A Phase Ib Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of APG-115 as a Single Agent or in Combination With Azacitidine or Cytarabine in Patients With Relapse/Refractory AML and Relapsed/Progressed High/Very High Risk MDS

Who is this study for? Patients with relapse/refractory AML and relapsed/progressed high/very high risk MDS
What treatments are being studied? APG-115
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation. APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models. This is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R/R AML or MDS subjects. Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia by WHO classification or relapsed/progressed high/very high risk MDS (score≥4.5) according to IPSS-R risk stratification

• Age \>/= 18 years.

• Adequate organ function

• Subject must have a projected life expectancy of at least 12 weeks.

• ECOG performance status of 0-1.

• Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.

• Subject has a white blood cell count\< 50 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.

Locations
Other Locations
China
The First Hospital of Peking University
NOT_YET_RECRUITING
Beijing
First Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital Central South University
RECRUITING
Changsha
Guangzhou panyu central hospital
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Shanghai Jiao Tong University school of medicine Ruijing Hospital
RECRUITING
Shanghai
Shanghai Sixth people's Hospital
RECRUITING
Shanghai
The First Affilated Hospital of Ganzhou Medical University
NOT_YET_RECRUITING
Suzhou
The First affiliated hospital of Soochow University
RECRUITING
Suzhou
Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Union Hospital medical college Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Henan Provincial Oncology Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Junyuan Qi, M.D.
qi_jy@yahoo.com
+86-18622662361
Backup
Bo Jiang, M.D.
jianbo044@163.com
+86-22-23909067
Time Frame
Start Date: 2020-07-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 102
Treatments
Experimental: APG-115/APG-115+Cytarabine in Relapse/Refractory AML
Experimental: APG-115/APG-115+Aza in relapsed/progressed high risk MDS
Sponsors
Leads: Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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