NCT05983276

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

Study Contact:

Patrick Stiff, MD - Role: CONTACT - Phone: 708-327-3148 - Email: pstiff@lumc.edu
Agnes Natonton, RN - Role: CONTACT - Phone: 708-327-3383 - Email: anatont@luc.edu

Study Phase:

PHASE2

Recruitment Status:

RECRUITING

NCT ID:

NCT05983276

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Combination of the Hypomethylating Agent Decitabine and the Nuclear Export Receptor XPO-1 Inhibitor Selinexor to Reverse Platinum Resistance in Relapsed/Refractory Epithelial Ovarian Cancer

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.

Eligibility

Inclusion Criteria:

* Participants must be greater than or equal to 18 years of age
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status PS less than or equal to 2.
* Participants must have histological or cytological proven epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma with relapse or disease progression after prior treatment by exam, computed tomography (CT), PET/CT, or magnetic resonance imaging (MRI) may be enrolled. All cell types including clear cell carcinoma are eligible.
* Participants must have failed or relapsed after a platinum and taxane containing combination
* Participants must have adequate hepatic function
* Participants must have adequate renal function
* Participants must be able to swallow and retain oral medications
* Participants must have measurable disease according to Gynecologic Cancer Intergroup CA125 criteria
* Participants with stable (for 2 months or longer), treated (by radiotherapy) CNS metastases are eligible
* Participants with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for greater than 8 weeks.

Exclusion Criteria:

* Participants must not have received Selinexor or another XPO1 inhibitor previously.
* Participants must not have had any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.)
* Participants must not have uncontrolled active infection. Participants on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
* Participants must not have known intolerance, hypersensitivity, or contraindication to platinum or taxane therapy
* Participants must not have active, unstable cardiovascular function
* Participants must not have myocardial infarction within 3 months prior to starting
* Participants with untreated central nervous system (CNS) metastases are ineligible.
* Participants must not have had prior chemotherapy or radiation therapy
* Participants must not have DVT related to metastatic disease requiring ongoing anticoagulation.

Disease(s) and\or Condition(s)

Ovarian Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Decitabine
- Description: 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.
- Arm Group Labels: Decitabine / Selinexor/ Carboplatin / Paclitaxel
- Type: DRUG
- Name: Carboplatin
- Description: Carboplatin is classified as an alkylating agent that is used to treat ovarian cancer.
- Arm Group Labels: Decitabine / Selinexor/ Carboplatin / Paclitaxel
- Type: DRUG
- Name: Paclitaxel
- Description: Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."
- Arm Group Labels: Decitabine / Selinexor/ Carboplatin / Paclitaxel
- Type: DRUG
- Name: Selinexor
- Description: Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.
- Arm Group Labels: Decitabine / Selinexor/ Carboplatin / Paclitaxel

Sponsor

Loyola University