Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of Safety, Pharmacokinetics and Efficacy of HMPL-523 With Azacitidine in Elderly Patients With Previously Untreated Acute Myeloid Leukemia
This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in previously untreated elderly patients with AML who are not eligible for standard induction therapy.
There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion
stage (stage 2).
Dose-escalation stage (stage 1):
The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional
3 patients to the same cohort to further evaluate toxicity) will be applied for dose
escalation and maximum tolerated dosage determination. Approximately 12 to 18 dose limited
toxicities evaluable patients will be enrolled. A dose of HMPL-523 up to 800mg will be taken
orally once daily continuously through a 28-day Cycle of study treatment. Azacitidine will be
administered subcutaneously, beginning on Day 1 through Day 7 of each Cycle.
Dose-expansion stage (stage 2):
This phase is to further evaluate the safety, pharmacokinetics and preliminary efficacy of
HMPL-523 in combination with Azacitidine in approximately 28 previously untreated elderly
patients with AML. Patients will receive HMPL-523 in combination with Azacitidine in a 28-day
cycle continuously until disease progression/relapse, death, or intolerable toxicity,
whichever comes first.
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