Clinical Trials for Homologous Recombination Deficiency Positive Advanced Ovarian Cancer
This article provides information about ongoing clinical trials for homologous recombination deficiency positive advanced ovarian cancer. Currently, there is 1 active trial evaluating new treatment approaches for patients with this specific subtype of advanced ovarian cancer. The trial is investigating whether a targeted oral medication can serve as an alternative to traditional chemotherapy.
Clinical trial locations
Study Comparing Niraparib and Platinum-Taxane Drug Combination for Patients with Advanced Ovarian Cancer
This clinical trial is designed to evaluate treatment options for patients with homologous recombination-deficient Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. The study compares the effectiveness of niraparib, an oral medication, with standard platinum-taxane doublet chemotherapy consisting of carboplatin and paclitaxel.
Main inclusion criteria:
- Female patients aged 18 years or older
- Newly diagnosed with Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer
- Disease that can be measured according to RECIST v1.1 guidelines
- Confirmed homologous recombination deficiency through tumor tissue testing
- Completed one cycle of carboplatin and paclitaxel chemotherapy (at least 50% of prescribed dose within 5 weeks) without disease progression
- No known allergies to carboplatin, paclitaxel, or niraparib
- Willingness to complete health questionnaires throughout the study
Main exclusion criteria:
- Male patients
- Ovarian cancer not confirmed as Stage III to IV
- Cancer that is not homologous recombination-deficient
- Patients outside the specified age range
- Vulnerable populations unable to provide informed consent
Focus and goals:
The trial aims to determine whether niraparib can serve as an effective alternative to traditional chemotherapy for patients with homologous recombination-deficient ovarian cancer. After completing an initial cycle of carboplatin and paclitaxel, participants are randomly assigned to receive either niraparib capsules taken orally or continued combination chemotherapy with carboplatin and paclitaxel given through intravenous infusion. Throughout the study, regular monitoring evaluates treatment response using established criteria. The trial also assesses safety and gathers information about patients’ quality of life through questionnaires. This research is part of a larger research effort called the OPAL Master Protocol, which explores new treatment approaches for ovarian cancer.
Investigational drugs:
The study focuses on niraparib, a PARP inhibitor that works by blocking an enzyme called poly (ADP-ribose) polymerase, which cancer cells use to repair damaged DNA. By preventing this repair mechanism, niraparib causes cancer cells to die. It is administered as 100 mg oral capsules. The comparison treatment consists of carboplatin and paclitaxel, two chemotherapy drugs commonly used together to treat ovarian cancer. Carboplatin damages cancer cell DNA to prevent growth and division, while paclitaxel stops cancer cells from dividing. Both are given through intravenous infusion.
Summary
Currently, only one clinical trial is actively recruiting patients with homologous recombination deficiency positive advanced ovarian cancer. This trial is being conducted in Spain and represents an important step in evaluating whether targeted oral therapies can replace or supplement traditional chemotherapy for this specific cancer subtype. The study focuses on patients with confirmed homologous recombination deficiency, a characteristic that makes cancer cells particularly vulnerable to PARP inhibitor medications like niraparib. The trial’s design, which includes an initial chemotherapy cycle followed by randomization to either continued chemotherapy or oral targeted therapy, allows researchers to directly compare these two treatment approaches in patients who have already demonstrated some response to initial treatment.
