Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

PHASE1TerminatedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

November 25, 2014

Primary Completion Date

August 21, 2020

Study Completion Date

August 21, 2020

Conditions
Acute Myelogenous LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

Milademetan

Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5 mg, 20 mg, 80 mg, and/or 200 mg

DRUG

AZA

AZA will be administered at 75 mg/m\^2 subcutaneously or intravenously

DRUG

Milademetan

Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 mg, 80 mg, and/or 100 mg milademetan may be utilized.

Trial Locations (5)

14263

Roswell Park Comprehensive Cancer Center, Buffalo

66205

University of Kansas Cancer Center, Fairway

77031

M D Anderson Cancer Center, Houston

91010

City of Hope National Medical Center, Duarte

94143

University of California San Francisco Medical Center, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY