NCT01915498 · OUTCOME

Phase 2: Apparent Terminal Phase Half-life (t1/2) of Enasidenib After Single and Multiple Oral Doses

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: hours
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.

What was measured

Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

Analysis population: Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1. t1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 2: Enasidenib 100 mg QD	19

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

Group	Source count
Phase 2: Enasidenib 100 mg QD	19

Values in hours · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Enasidenib 100 mg QD	38.3	81.7	Not reported	Not reported	Not reported

Cycle 2, Day 1

Analysis denominator · Participants

Group	Source count
Phase 2: Enasidenib 100 mg QD	0

Complete source fields

classes

categories
measurements
group Id
OG000
spread
81.7
value
38.3
denoms
counts
group Id
OG000
value
19
units
Participants
title
Cycle 1, Day 1
denoms
counts
group Id
OG000
value
0
units
Participants
title
Cycle 2, Day 1

denoms

counts
group Id
OG000
value
19
units
Participants

description

Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG000
title
Phase 2: Enasidenib 100 mg QD

param Type

GEOMETRIC_MEAN

population Description

Participants who received enasidenib on Cycle 1 Day 1 or Cycle 2 Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2 Day 1. t1/2 was not calculated when the terminal elimination rate constant (λz) was not estimable.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 and Cycle 2 Day 1 at predose and 2, 4, 6, 8, and 24 hours post-dose.

title

Phase 2: Apparent Terminal Phase Half-life (t1/2) of Enasidenib After Single and Multiple Oral Doses

type

SECONDARY

unit Of Measure

hours

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice