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NCT02323880 · OUTCOME

Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients

Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas · Source last updated 2025-01-14

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

Measure
MEDIAN
Unit
Ratio of XPO1 mRNA expression
Interval / dispersion
Full Range
Time frame
Up to 28 days

What was measured

Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose

Analysis population: high-grade glioma (HGG) patients with data available

Groups in this outcome

Part A: Weekly Dose Level 1 (WDL 1)

45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

Part B: Weekly Dose Level -1 (WDL -1)

35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

Part PK: Weekly Dose Level -1 (WDL -1)

35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day 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
Part A: Weekly Dose Level 1 (WDL 1)1
Part B: Weekly Dose Level -1 (WDL -1)4
Part PK: Weekly Dose Level -1 (WDL -1)1

Reported measurements

Source class 1
Values in Ratio of XPO1 mRNA expression · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Weekly Dose Level 1 (WDL 1)4.2Not reported4.24.2Not reported
Part B: Weekly Dose Level -1 (WDL -1)4.6Not reported1.25.3Not reported
Part PK: Weekly Dose Level -1 (WDL -1)5.9Not reported5.95.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        4.2
        value
        4.2
      2. group Id
        OG001
        lower Limit
        1.2
        upper Limit
        5.3
        value
        4.6
      3. group Id
        OG002
        lower Limit
        5.9
        upper Limit
        5.9
        value
        5.9
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
dispersion Type
Full Range
groups
  1. description
    45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    OG000
    title
    Part A: Weekly Dose Level 1 (WDL 1)
  2. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    OG001
    title
    Part B: Weekly Dose Level -1 (WDL -1)
  3. description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    OG002
    title
    Part PK: Weekly Dose Level -1 (WDL -1)
param Type
MEDIAN
population Description
high-grade glioma (HGG) patients with data available
reporting Status
POSTED
time Frame
Up to 28 days
title
Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients
type
SECONDARY
unit Of Measure
Ratio of XPO1 mRNA expression

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice