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NCT02989857 · OUTCOME

Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: B (Baseline Effect Value)

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
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days)

What was measured

B is the Baseline Effect Value. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint.

Analysis population: Pharmacodynamic (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-120142

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Randomization Phase AG-120 Plus Cross Over Phase AG-120142
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomization Phase AG-120 Plus Cross Over Phase AG-1201107.701709.919Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Randomization Phase AG-120 Plus Cross Over Phase AG-120108
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Randomization Phase AG-120 Plus Cross Over Phase AG-120795.09938.677Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1709.919
        value
        1107.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        938.677
        value
        795.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    units
    Participants
description
B is the Baseline Effect Value. 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
Pharmacodynamic (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: B (Baseline Effect Value)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice