Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

PHASE1TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 30, 2017

Primary Completion Date

August 14, 2018

Study Completion Date

August 14, 2018

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)Chronic Myelomonocytic Leukemia (CMML)
Interventions
DRUG

IRX5183

IRX5183 will be administered orally daily on days 1-28 of each cycle for 2 cycles of induction. In the phase I part of the study, there will be 3 dose levels (dose level 1 \[DL1\] with 50 mg, DL2 with 75 mg, and DL3 with 100 mg), with 1 additional dose level to be only used if excessive toxicity noted at the DL1. There will be no intra-patient dose escalation. A phase II portion of the study was originally planned, but the study was terminated prior to phase II enrollment.

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Io Therapeutics

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER