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A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia
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:
•Newly diagnosed patients who are ineligible for standard therapy i.e., standard dose induction chemotherapy and reduced dose chemotherapy
•Patients with relapse from prior remission
•Patients with failed response to prior therapy including chemotherapy, hypomethylating agents, and bone marrow (BM) transplantation. 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.