A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage. APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycle. Initially, the start dose is 20mg. Single patient cohorts ...
This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage. APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycle. Initially, the start dose is 20mg. Single patient cohorts will be evaluated, the dose of APG-2575 will be increased in subsequent cohorts, to 50 mg, 100 mg, 200 mg, 400 mg, 600mg and 800mg accordingly. If there is any one of the following event is observed, a dose-limiting toxicity (DLT), two drug related Grade 2 toxicities or one drug related ? Grade 3 toxicity, or laboratory or clinical tumor lysis syndrome (TLS), or suspected hypersensitivity reaction occur in Cycle 1, the dose escalation will convert to the standard 3+3 design, If ? 2/6 patients develop DLT at any dose level dose escalation will cease and the dose level immediately below will be expanded to 6 patients. If ? 1/6 patients develop a DLT at the highest dose reached this will be declared the MTD. After the MTD/Recommended Phase II Dose (RP2D) is defined, a maximum of 40 patients will be treated at that dose level.
Tracking Information
- NCT #
- NCT03913949
- Collaborators
- Suzhou Yasheng Pharmaceutical Co., Ltd.
- Investigators
- Principal Investigator: Jianxiang Wang, MD Blood Diseases Hospital Chinese Academy of Medical Sciences