Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
HP Version - Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
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Closed (no longer recruiting)Last updated: 30 January 2024
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This is a multicenter, single arm, non-randomised Phase IIA Study to evaluate ASLAN003 as a monotherapy in patients with AML. AML patients who are ineligible for standard treatment including, but not limited to the following conditions, will be enrolled in the study:
Up to a total of 18 patients will be enrolled into this study - 6 patients in each dose cohort (ASLAN003 100 mg once daily (QD), 200 mg QD, and 300 mg QD, respectively). Once 6 patients have been enrolled into the cohort of 100 mg QD, recruitment will be started in the cohort of 200 mg QD. The same rule applies on the cohort of 300 mg QD. A steering committee (SC) meeting will be set up and meet to review all safety data. Clinical information, including safety and PK data obtained from this Study, will be reviewed by a SC. All patients will continue to receive ASLAN003 until disease relapse, treatment failure, unacceptable toxicity, withdrawal of consent or death.
This trial is treating patients with Acute Myeloid Leukaemia (AML).
Haematological
21+
II
ASLAN003-003
Use the hyperlinks, where available to access additional clinical trial information.
Aslan Pharmaceuticals
A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia
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Note: Patients who do not have sufficient archival BM aspiration sample and refuse to repeat the procedure may be enrolled in the trial only after written confirmation by ASLAN 5. Part 1: Patients who are ineligible for standard treatment of AML including to the following conditions:
Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation.
5. Part 2A: Patients who have relapsed or refractory AML to treatments including chemotherapy, hypomethylating agents, bone marrow transplantation, and other anti-leukemic agents
Refractory patients who have no CR or CRi after 2 courses of intensive induction treatment 5. Part 2B: Older patients (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.
6. Patients who have an ECOG performance status of ≤ 2 7. Patients with adequate renal and hepatic function, as defined below:
Clinical trials have complex eligibility criteria.
Ask your doctor if this trial could be right for you.
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