NCT01915498 · OUTCOME

Phase 2: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib

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: ng/mL
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

AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 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.

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	91

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

Group	Source count
Phase 2: Enasidenib 100 mg QD	91

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Enasidenib 100 mg QD	72	80.8	Not reported	Not reported	Not reported

Cycle 2, Day 1

Analysis denominator · Participants

Group	Source count
Phase 2: Enasidenib 100 mg QD	68

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Enasidenib 100 mg QD	1158	48.5	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
80.8
value
72
denoms
counts
group Id
OG000
value
91
units
Participants
title
Cycle 1, Day 1
categories
measurements
group Id
OG000
spread
48.5
value
1158
denoms
counts
group Id
OG000
value
68
units
Participants
title
Cycle 2, Day 1

denoms

counts
group Id
OG000
value
91
units
Participants

description

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.

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: Maximum Concentration (Cmax) of AGI-16903 After Single and Multiple Oral Doses of Enasidenib

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice