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APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies
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.
Study details:
APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycles. 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 DLT, two drug related Grade 2 toxicities or one drug related ≥ Grade 3 toxicity, or laboratory or clinical TLS, or suspected hypersensitivity reaction occur in Cycle 1, or dose level of 400 mg is reached, 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 is defined, a maximum of 20 patients will be treated at that dose level.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-08-07
Primary completion: 2024-09-15
Study completion finish: 2025-02-15
Study type
TREATMENT
Phase
EARLY_PHASE1
Trial ID
NCT03537482
Intervention or treatment
DRUG: APG-2575
Conditions
- • Hematologic Malignancies
Find a site
Closest Location:
St. Vincent Hospital
Research sites nearby
Select from list below to view details:
St. Vincent Hospital
Fitzroy, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: single-agent, open-label, Phase I study of APG-2575
| DRUG: APG-2575
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD) | Patients with APG-2575 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.0 | 28 days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) will be assessed in the patients treated with APG-2575 | 28 days |
Area under the plasma concentration versus time curve (AUC) | Area under the plasma concentration versus time curve (AUC) of APG-2575 will be assessed in the patients treated with APG-2575 | 28 days |
Anti-tumor effects of APG-2575 | Response will be evaluated every 2 cycles (8 weeks), by the investigator based on disease specific criteria. | up to 2 years |
Frequently Asked Questions
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