NCT04256707 · OUTCOME

Monotherapy: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-Inf) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment · Source last updated 2026-10-09

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

Measure: GEOMETRIC_MEAN
Unit: h*ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8

What was measured

AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), calculated as AUC0-last + Ct/λ, where: Ct = the last quantifiable concentration and λ is terminal elimination rate constant.

Analysis population: PK analysis was defined as all participants in the monotherapy part who received at least 1 dose of selinexor and had at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of selinexor (e.g., vomited at or before 6 hours; wrong dose administered; prohibited concomitant medication). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.

Groups in this outcome

Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function

Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.

Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function

Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.

Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function

Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.

Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function

Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.

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

Analysis denominator · Participants

Group	Source count
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function	19
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function	19
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function	6
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function	5

Reported measurements

Source class 1

Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function	6880	28.7	Not reported	Not reported	Not reported
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function	6980	27.1	Not reported	Not reported	Not reported
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function	2270	16.3	Not reported	Not reported	Not reported
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function	4060	24.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
28.7
value
6880
group Id
OG001
spread
27.1
value
6980
group Id
OG002
spread
16.3
value
2270
group Id
OG003
spread
24.4
value
4060

denoms

counts
group Id
OG000
value
19
group Id
OG001
value
19
group Id
OG002
value
6
group Id
OG003
value
5
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
id
OG000
title
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
description
Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
id
OG001
title
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
description
Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
id
OG002
title
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function
description
Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
id
OG003
title
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function

param Type

GEOMETRIC_MEAN

population Description

PK analysis was defined as all participants in the monotherapy part who received at least 1 dose of selinexor and had at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of selinexor (e.g., vomited at or before 6 hours; wrong dose administered; prohibited concomitant medication). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8

title

Monotherapy: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-Inf) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

type

PRIMARY

unit Of Measure

h*ng/mL

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Preserved source evidence · Not medical advice