drugset
drugset / Trial / NCT04926285

Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)

NCT04926285 ↗

Phase 1 Completed 6 enrolled University of Illinois at Chicago
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an induction phase, followed by a consolidation phase if applicable.

Timeline

Start
2022-06-21
Primary completion
2024-01-29
Completion
2025-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Omacetaxine Unknown 0.625 mg/m2 Subcutaneous
Subject Omacetaxine Unknown 1.25 mg/m2 Subcutaneous
Subject Omacetaxine Unknown 2 mg/m2 Subcutaneous
Subject Omacetaxine Unknown 2.5 mg/m2 Subcutaneous
Subject Venetoclax Small molecule 400 mg Oral

Indications

refractory hematologic cancer