Spots Global Cancer Trial Database for A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
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Trial Identification
Brief Title: A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Official Title: 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
Study ID: NCT04275518
Study Description
Brief 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).
Detailed Description: Stage 1: This will be a 3+3 dose escalation to determine the DLTs and MTD/RP2D of APG-115 given according to the different dose levels once daily from Days 1 to 7 every 28 days. Stage 2: After stage 1 of APG-115 single agent dose escalation first cycle is completed, stage 2 can be initiated with the combination regimen. This will be a 3+3 dose escalation to determine the MTD/RP2D and DLTs of APG-115 + AZA(arm A)/Cytarabine (arm B)combination. Stage 3: dose expansion of the combination regimes.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Hospital of Peking University, Beijing, Beijing, China
Guangzhou panyu central hospital, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Henan Provincial Oncology Hospital, Zhengzhou, Henan, China
Union Hospital medical college Huazhong University of Science and Technology, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The First Affilated Hospital of Ganzhou Medical University, Suzhou, Jiangsu, China
The First affiliated hospital of Soochow University, Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
First Hospital of Jilin University, Changchun, Jilin, China
Shanghai Jiao Tong University school of medicine Ruijing Hospital, Shanghai, Shanghai, China
Shanghai Sixth people's Hospital, Shanghai, Shanghai, China
Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
Contact Details
Name: Jianxiang Wang, M.D.
Affiliation: Blood Diseases Hospital Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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