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Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment

NCT04256707 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-03-19

No results posted yet for this study

Summary

This is a Phase 1/2, two-part, multi-arm, open-label study in patients with normal Hepatic Function (HF), with either Non-small cell lung cancer (NSCLC), who have had 1-2 prior lines of treatment, with 1 line containing a checkpoint Inhibitor (CPI); or patients with normal HF, with colorectal cancer (CRC) who have had 1-3 prior lines (KRAS wild-type \[WT\]) or 1-2 prior lines (mutant KRAS) of treatment with no CPI; or patients with impaired HF, with any solid tumor, who have had at least 1 prior line of treatment.

The study will comprise 2 treatment periods (monotherapy and combination therapy).

The purposes of this study, during Monotherapy period, are: (1) to determine the relative bioavailability of the 100 milligrams (mg) (Tablet B) and 20 mg (Tablet A) tablets of selinexor at 100 mg once weekly (QW) dose in patients with normal hepatic function; and (2) to assess the PK of selinexor after a single dose of 40 mg (2 × 20 mg), among patients with moderate and severe hepatic impairment, relative to 100 mg (5 × 20 mg), among patients with normal hepatic function; and, during the Combination therapy period, to assess the preliminary anti-tumor activity of selinexor in combination with docetaxel in patients with NSCLC and with pembrolizumab or folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) in patients with CRC.

Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Colorectal Cancer (CRC)
  • Other Solid Tumors

Interventions

DRUG

Selinexor 100 mg

100-mg 2 formulations: * 5 × 20-mg tablets (Tablet A) * 1 × 100-mg tablet (Tablet B)

DRUG

Docetaxel

75 mg/m\^2 IV

DRUG

Pembrolizumab

200 mg IV

DRUG

FOLFIRI

FOLFIRI: * Irinotecan 180 mg/m\^2 * Leucovorin 400 mg/m\^2 * 5-FU 400 mg/m\^2 bolus * 5-FU 2400 mg/m\^2 IV

DRUG

Selinexor 40 mg

\- 2 × 20-mg tablets (Tablet A)

DRUG

Selinexor 80 mg

\- 4 × 20-mg tablets (Tablet A)

DRUG

Selinexor 60 mg

\- 3× 20-mg tablets (Tablet A)

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256707 on ClinicalTrials.gov