NCT04256707 · OUTCOME

Monotherapy: Maximum Plasma Concentration (Cmax) 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: nanograms per milliliter (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

Cmax was defined as maximum observed plasma total-drug concentration of selinexor.

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).

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	7
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function	6

Reported measurements

Source class 1

Values in nanograms per milliliter (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	782	40.8	Not reported	Not reported	Not reported
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function	813	25.6	Not reported	Not reported	Not reported
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function	272	36.4	Not reported	Not reported	Not reported
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function	372	42.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
40.8
value
782
group Id
OG001
spread
25.6
value
813
group Id
OG002
spread
36.4
value
272
group Id
OG003
spread
42.1
value
372

denoms

counts
group Id
OG000
value
19
group Id
OG001
value
19
group Id
OG002
value
7
group Id
OG003
value
6
units
Participants

description

Cmax was defined as maximum observed plasma total-drug concentration of selinexor.

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).

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: Maximum Plasma Concentration (Cmax) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

type

PRIMARY

unit Of Measure

nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice