Status:
RECRUITING
Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Karyopharm Therapeutics Inc
Conditions:
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
Participants enrolled in this study protocol will receive therapy with decitabine followed by usual doses of carboplatin and paclitaxel for one cycle. If the participant tolerates this well, the selin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05983276
Start Date
November 16 2023
End Date
August 28 2031
Last Update
February 8 2024
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153