NCT03483948

Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia

A Phase I Study of Safety, Pharmacokinetics and Efficacy of HMPL-523 With Azacitidine in Elderly Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	HMPL-523	HMPL-523 tablet
DRUG	Azacitidine	Azacitidine Injection

Timeline

• Start date: 2018-10-09
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2018-03-30
• Last updated: 2019-11-20

Locations

1 site across 1 country: China