APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03537482|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : August 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: APG-2575||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||dose escalation and dose expansion after MTD|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Property of Orally Administered APG-2575 in Patients With Hematologic Malignancies|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||September 15, 2022|
|Estimated Study Completion Date :||February 15, 2023|
Experimental: 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 as an oral tablet
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]Patients with APG-2575 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.0
- Maximum plasma concentration (Cmax) [ Time Frame: 28 days ]Maximum plasma concentration (Cmax) will be assessed in the patients treated with APG-2575
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 28 days ]Area under the plasma concentration versus time curve (AUC) of APG-2575 will be assessed in the patients treated with APG-2575
- Anti-tumor effects of APG-2575 [ Time Frame: up to 2 years ]Response will be evaluated every 2 cycles (8 weeks), by the investigator based on disease specific criteria.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥18 years old.
- Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid leukemia
Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In addition,
a. AML Patients will be eligible if they have failed standard induction regimen, are not considered candidate for further chemotherapy or stem cell transplantation or have primary refractory AML.
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion.
- QTc interval ≤450ms in males, and ≤470ms in females.
- Adequate bone marrow function independent of growth factor:
- Absolute neutrophil count (ANC) ≥1.0 X 109/L.
- Hemoglobin ≥ 8.0 g/dL.
- Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion within 7 days of first dose).
- Adequate renal and liver function as indicated by:
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 (42 days for nitrosoureas or mitomycin C) 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.
- 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.
- 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.
- Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
- Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
- Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
- Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537482
|Contact: Laura Glass||301-520-5964||Laura.Glass@ascentage.com|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Contact: Sikander Ailawadhi, MD 904-953-0853 email@example.com|
|Principal Investigator: sikander ailawdhi, md|
|United States, North Carolina|
|Durham, North Carolina, United States, 27701|
|Contact: danielle brander, MD 919-684-8000 firstname.lastname@example.org|
|Principal Investigator: Danielle Brander, MD|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Contact: Tapan Kadia, MD 713-792-7734 email@example.com|
|Principal Investigator: Tapan Kadia, MD|
|St. Vincent Hospital||Recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Contact: lisa demosthenous 61-3-9231-3630 firstname.lastname@example.org|
|Principal Investigator: Masa Lasica, MD|
|Richmond, Victoria, Australia, 3121|
|Contact: andrew Karapetis, MD 37-817-7762 email@example.com|
|Principal Investigator: Costas Yannakou, MD|
|Study Chair:||Yifan Zhai, MD, PhD||Ascentage Pharma Group Inc.|
|Responsible Party:||Ascentage Pharma Group Inc.|
|Other Study ID Numbers:||
|First Posted:||May 25, 2018 Key Record Dates|
|Last Update Posted:||August 16, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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