Eganelisib

A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

What's the purpose of the trial?

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS). The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination. * Part 2: Dose Optimization

Trial status

Accepting patients

Phase

Phase 1

Enrollment

125

Last Updated

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Participating Centers

There are 16 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

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Eganelisib (IPI-549)
Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.

Arms / Cohorts

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Accepting patients

Eganelisib

Accepting patients

Eganelisib in Combination with Cytarabine

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