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NCT01915498 · OUTCOME

Phase 2: Time to Maximum Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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

GroupSource count
Phase 2: Enasidenib 100 mg QD91

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD91
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD8.00Not reported2.0029.02Not reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD68
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD2.12Not reported0.0023.92Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.00
        upper Limit
        29.02
        value
        8.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        23.92
        value
        2.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Cycle 2, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    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
Full Range
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
MEDIAN
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: Time to Maximum Concentration (Tmax) 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