Study on Niraparib and Selenium for Treating Recurrent BRCA Negative Ovarian Cancer Resistant to Platinum Therapy
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT05672095
This clinical trial is testing a new combination of drugs, niraparib and selenium, to see if they are safe and effective in treating ovarian cancer that has returned and does not respond to standard platinum-based treatments. The study aims to find the best dose and evaluate the impact on tumor growth and patient quality of life.
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Program Overview
This study is exploring a new treatment for ovarian cancer that has come back and is resistant to platinum-based therapy. The treatment combines two drugs: niraparib, which helps kill cancer cells, and selenium, a trace element that may help prevent cancer growth. The trial will test the safety and effectiveness of this combination, aiming to find the best dose and see if it can improve patient outcomes, including tumor control and quality of life.
Description
The study is divided into two phases. In Phase I, researchers will assess the safety and feasibility of the niraparib and selenium combination. In Phase II, they will evaluate how well the treatment works in controlling cancer, focusing on progression-free survival and overall response rates. The study will also look at the impact on patients' quality of life and monitor any side effects, such as nausea and fatigue.
Participants will receive selenium through an IV and take niraparib orally. They will undergo regular scans, biopsies, and blood tests to track the treatment's effects. The study will also explore how the treatment affects cancer at a molecular level, using advanced techniques to analyze tumor samples before and after treatment.
The trial includes a dose-escalation phase to find the safest and most effective dose, followed by a dose-expansion phase to further evaluate the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer that is recurrent and resistant to platinum-based therapy.
- Must have measurable or evaluable disease based on specific medical criteria.
- Must have had no more than four prior chemotherapy treatments.
- Must have specific blood counts and organ function within acceptable limits.
- Must not have BRCA mutations or homologous recombination deficiency (HRD).
- Must agree to use effective birth control during the study and for 180 days after the last dose if of childbearing potential.
- Must provide informed consent and agree to study procedures.
Exclusion Criteria
- Cannot have received chemotherapy, biological therapy, or immunotherapy within 21 days before starting the study.
- Cannot have had recent radiation therapy or blood transfusions.
- Cannot have other active cancers or have been treated for another cancer within the last two years, except for certain skin or cervical cancers.
- Cannot be taking certain medications or supplements that may interfere with the study drugs.
- Cannot have a history of severe allergic reactions to similar drugs.
- Cannot have uncontrolled medical conditions, such as high blood pressure or active infections.
- Cannot be pregnant or breastfeeding.
- Cannot have had major surgery recently or have certain medical conditions that may affect participation in the study.
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