Actively Recruiting
Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
Led by Loyola University · Updated on 2024-02-08
40
Participants Needed
1
Research Sites
406 weeks
Total Duration
On this page
Sponsors
L
Loyola University
Lead Sponsor
K
Karyopharm Therapeutics Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with relapse or progression after prior treatment
- Relapse or failure after platinum and taxane chemotherapy
- Adequate liver function
- Adequate kidney function
- Ability to swallow and keep oral medications
- Measurable disease based on Gynecologic Cancer Intergroup CA125 criteria
- Stable and treated central nervous system metastases for 2 months or longer
- If hepatitis B positive, must have at least 8 weeks of antiviral therapy
You will not qualify if you...
- Previous treatment with selinexor or other XPO1 inhibitors
- Any uncontrolled active medical condition or disease such as uncontrolled hypertension, diabetes, or active systemic infection
- Uncontrolled active infection (controlled infections or prophylactic antibiotics within 1 week prior to first treatment allowed)
- Known intolerance or allergy to platinum or taxane therapy
- Active unstable heart conditions
- Heart attack within 3 months before starting treatment
- Untreated central nervous system metastases
- Previous chemotherapy or radiation therapy
- Deep vein thrombosis related to metastatic disease requiring ongoing blood thinning treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
Research Team
P
Patrick Stiff, MD
CONTACT
A
Agnes Natonton, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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