NCT05983276 Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
| NCT ID | NCT05983276 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Loyola University |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2030-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-11-16 with a primary completion date of 2030-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Patrick L Stiff, MD
PRINCIPAL INVESTIGATOR
Loyola University
Frequently Asked Questions
Who can join the NCT05983276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05983276 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05983276 currently recruiting?
Yes, NCT05983276 is actively recruiting participants. Contact the research team at pstiff@lumc.edu for enrollment information.
Where is the NCT05983276 trial being conducted?
This trial is being conducted at Maywood, United States.
Who is sponsoring the NCT05983276 clinical trial?
NCT05983276 is sponsored by Loyola University. The principal investigator is Patrick L Stiff, MD at Loyola University. The trial plans to enroll 40 participants.
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