A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies (NCT03913949) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies
China74 participantsStarted 2019-06-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.