A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Properties of Orally Administered APG-2575 in Patients With Hematologic Malignancies

Ascentage Pharma Group Inc.6 个研究点分布在 1 个国家目标入组 74 人2019年6月3日

适应症Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma

干预措施APG-2575

概览

阶段: 1 期
干预措施: APG-2575
疾病 / 适应症: Chronic Lymphocytic Leukemia
发起方: Ascentage Pharma Group Inc.
入组人数: 74
试验地点: 6
主要终点: Maximum Tolerated Dose (MTD)
状态: 进行中（未招募）
最后更新: 昨天

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic properties of APG-2575 in patients with relapse or refractory chronic lymphocytic leukemia and non-hodgkin's lymphoma.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2019年6月3日

结束日期

2026年12月31日

最后更新

昨天

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Ascentage Pharma Group Inc.

责任方

Sponsor

入排标准

入选标准

•Age ≥18 years old.
•Histologically confirmed diagnosis of chronic lymphocytic leukemia, or non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM).
•Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit.
•Life expectancy ≥ 3 months.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation; 0-2 in dose expansion.
•Corrected QT interval ≤450ms in males, and ≤470ms in females.
•Adequate bone marrow function independent of growth factor:
•Absolute neutrophil count (ANC) ≥1.0 X 10E9/L.
•Hemoglobin ≥ 8.0 g/dL.
•Platelets count ≥ 30 X 10E9/L (entry platelet count must be independent of transfusion within 7 days of first dose).

排除标准

•Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
•Prior history of allogeneic cell transplant.
•Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
•Received chemotherapy within 14 days prior to entering the study.
•Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
•Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy.
•Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
•Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.
•Has known active central nervous system (CNS) involvement.
•Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.