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Tests treatment safety and results for Hematologic Malignancies
Official title APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT03537482
What this study is testing
What is APG-2575?
APG-2575 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hematologic malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old.
- Histologically confirmed diagnosis of either one of the B-cell hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia...
- Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. In...
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation ; 0-2 in dose expansion.
You likely can't join if
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- Prior history of allogeneic cell transplant.
- people 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Fitzroy, Victoria, Australia
- Richmond, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Durham, North Carolina, United States; Houston, Texas, United States; Fitzroy, Victoria, Australia; Richmond, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.