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New treatment option for Ovarian Cancer
Official title Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer
ClinicalTrials.gov ID: NCT05983276
What this study is testing
What is Decitabine?
Decitabine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Also referred to as Dacogen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must have failed or relapsed after a platinum and taxane containing combination
- Participants must have adequate hepatic function
You likely can't join if
- 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...
- Participants must not have uncontrolled active infection. Participants on prophylactic antibiotics or with a controlled infection within 1 week prior...
- 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Maywood, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maywood, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.