NCT05983276RecruitingPhase 2
Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- 16 Nov 2023
- Primary completion date
- 28 Aug 2030
- Lead sponsor
- Loyola University
- Diseases
- Ovarian cancer
- NCT number
- NCT05983276
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 16 Nov 2023 to the primary completion date, 28 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 myocardial infarction within 3 months prior to starting
- Participants must not have had prior chemotherapy or radiation therapy
Other illness
- Participants must not have known intolerance, hypersensitivity, or contraindication to platinum or taxane therapy
- Participants must not have DVT related to metastatic disease requiring ongoing anticoagulation.
Other
- Participants must not have active, unstable cardiovascular function
- Participants with untreated central nervous system (CNS) metastases are ineligible.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.