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NCT04256707 · OUTCOME

Combination Therapy (Arms: A, B and C): Disease Control Rate (DCR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 25 months

What was measured

DCR was calculated as the percentage of participants for whom the best overall response (BOR) was determined as CR, PR, or at least 12 continuous weeks of stable disease as assessed by RECIST v1.1 (Arms A, C), and iRECIST (Arm B), before Investigator had determined PD or initiating a new antineoplastic therapy. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) might have reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: MITT population for the combination period included all participants who received at least 1 dose of selinexor in the combination therapy period.

Groups in this outcome

Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel

Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.

Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab

Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.

Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)

Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.

Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)

Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.

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

Analysis denominator · Participants

GroupSource count
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel17
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab38
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)6
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)2

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel58.8Not reported32.981.6Not reported
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab28.9Not reported15.445.9Not reported
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)0Not reported00Not reported
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)50Not reported1.398.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.9
        upper Limit
        81.6
        value
        58.8
      2. group Id
        OG001
        lower Limit
        15.4
        upper Limit
        45.9
        value
        28.9
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
      4. group Id
        OG003
        lower Limit
        1.3
        upper Limit
        98.7
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      38
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      2
    units
    Participants
description
DCR was calculated as the percentage of participants for whom the best overall response (BOR) was determined as CR, PR, or at least 12 continuous weeks of stable disease as assessed by RECIST v1.1 (Arms A, C), and iRECIST (Arm B), before Investigator had determined PD or initiating a new antineoplastic therapy. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) might have reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.
    id
    OG000
    title
    Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel
  2. description
    Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.
    id
    OG001
    title
    Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab
  3. description
    Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
    id
    OG002
    title
    Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
  4. description
    Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
    id
    OG003
    title
    Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
param Type
NUMBER
population Description
MITT population for the combination period included all participants who received at least 1 dose of selinexor in the combination therapy period.
reporting Status
POSTED
time Frame
Up to 25 months
title
Combination Therapy (Arms: A, B and C): Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice