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
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 is classified as an alkylating agent that is used to treat ovarian cancer.
- DRUG
-
Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."
- DRUG
-
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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