This is a 2-part, open-label, interventional study conducted in approximately 42 subjects
with AML harboring an IDH2 mutation.
The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on
the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2).
Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14
subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the
respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part
Subjects can only be enrolled in one treatment arm. The probes (which are given twice) used
in the study are approved for use in the countries where the study will be conducted. The
probes in Arm 1 consist of single doses of caffeine (100mg), dextromethorphan (30 mg),
flurbiprofen (50 mg), midazolam (0.03 mg/kg), and omeprazole (40 mg). Arm 2 probes consist of
digoxin (0.25 mg), and rosuvastatin (10 mg). Arm 3 probe is pioglitazone (15 mg). Enasidenib
is administered orally. All probes, except for midazolam, are administered orally. Midazolam
will be administered intravenously.
In Part 1 (equivalent to Cycle 1), eligible subjects will receive the probes on Day -1,
followed by the first dose of enasidenib on Day 1. Enasidenib will continue to be taken once
daily for 28 days. Blood samples for pharmacokinetic analysis will be collected according to
a set schedule. Subjects will receive the probes a second time on Day 28. Part 2 of the study
begins the next day when the subject begins a second round of daily enasidenib doses
(equivalent to Cycle 2). Safety assessment s and procedures consistent with AML standard of
care will continue.
Arm 1 probes,
Arm 2 Probes,
Arm 3 probes
Clinical Study Identifier
Last Modified on
30 July 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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