NCT04187495

Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

A Phase I Study for Tolerance and Pharmacokinetic Characteristic of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Maxinovel Pty., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.

Detailed description

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	MAX-40279-01	Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1. For each dose level, a single dose of MAX-40279-01 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle).

Timeline

• Start date: 2019-04-16
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-12-05
• Last updated: 2022-01-19

Locations

1 site across 1 country: China