NCT05983276 · Loyola University
Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
What this study 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.
View original scientific description
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.
Interventions
DRUG
Decitabine
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.
DRUG
Carboplatin
Carboplatin is classified as an alkylating agent that is used to treat ovarian cancer.
DRUG
Paclitaxel
Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."
DRUG
Selinexor
Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.
Primary outcome measures
40 participants evaluated for safety with treatment-related adverse events and grading using CTCAE 4.3.
Time frame: 6 months
To determine the safety of two agents in combination to reverse platinum resistance in ovarian cancer: the hypomethylating agent, decitabine, and the nuclear export receptor XPO1 inhibitor, selinexor, combined with carboplatin and paclitaxel in patients with relapsed/refractory epithelial ovarian carcinoma
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Maywood, Illinois
Collaborators
Karyopharm Therapeutics Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 8, 2024 · Source of record for eligibility and locations