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NCT02989857 · OUTCOME

Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BAUEC0-4

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20

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

Measure
MEAN
Unit
percent
Interval / dispersion
Standard Deviation
Time frame
Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days)

What was measured

%BAUEC0-4 is the percent inhibition for AUEC0-4. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint.

Analysis population: PD Analysis Population consisted of all participants who were enrolled and received any dose of study medication (AG-120) with sufficient plasma sample data to assess pharmacodynamic parameters. Number analyzed is the number of participants with data available for analyses at the specified time point.

Groups in this outcome

Randomization Phase AG-120 Plus Cross Over Phase AG-120

Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study. Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
Randomization Phase AG-120 Plus Cross Over Phase AG-120141

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Randomization Phase AG-120 Plus Cross Over Phase AG-120141
Values in percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomization Phase AG-120 Plus Cross Over Phase AG-12020.2209010.13659Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Randomization Phase AG-120 Plus Cross Over Phase AG-120107
Values in percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomization Phase AG-120 Plus Cross Over Phase AG-12074.975022.53852Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.13659
        value
        20.22090
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.53852
        value
        74.9750
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    units
    Participants
description
%BAUEC0-4 is the percent inhibition for AUEC0-4. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study. Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle.
    id
    OG000
    title
    Randomization Phase AG-120 Plus Cross Over Phase AG-120
param Type
MEAN
population Description
PD Analysis Population consisted of all participants who were enrolled and received any dose of study medication (AG-120) with sufficient plasma sample data to assess pharmacodynamic parameters. Number analyzed is the number of participants with data available for analyses at the specified time point.
reporting Status
POSTED
time Frame
Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days)
title
Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BAUEC0-4
type
SECONDARY
unit Of Measure
percent

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

Preserved source evidence · Not medical advice