Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01915498 · OUTCOME

Phase 2: Apparent Terminal Phase Half-life (t1/2) 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
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

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. 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

GroupSource count
Phase 2: Enasidenib 100 mg QD4

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD4
Values in hours · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD32.2116.9Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        116.9
        value
        32.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 1, Day 1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 2, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
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.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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 AGI-16903 After Single and Multiple Oral Doses of Enasidenib
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice