Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer

NCT05983276 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the side effects and effectiveness of this novel four-drug combination of chemotherapy (decitabine, selinexor, carboplatin and paclitaxel) on patients with relapsed ovarian, fallopian or primary peritoneal carcinoma.

Recently the investigators have found that the combination of decitabine and selinexor, two Food and Drug Administration (FDA) approved chemotherapy agents, may prevent or reverse the development of drug resistance and further the remissions and duration of remissions with standard ovarian cancer chemotherapy with carboplatin and paclitaxel. As decitabine and selinexor are not FDA approved for the participant's cancer, these agents are investigational.

Conditions

Interventions

DRUG

Decitabine

Decitabine is classified as hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow.

DRUG

Carboplatin

Carboplatin is classified as an alkylating agent that is used to treat ovarian cancer.

DRUG

Paclitaxel

Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."

DRUG

Selinexor

Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY
  • Loyola University

    lead OTHER

Principal Investigators

  • Patrick L Stiff, MD · Loyola University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2030-08-28
Completion
2031-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05983276 on ClinicalTrials.gov