PARP Inhibitors for Ovarian Cancer
(4PDQ Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Niraparib for ovarian cancer?
Niraparib has been shown to increase the time patients live without their cancer getting worse (progression-free survival) in those with recurrent ovarian cancer after platinum-based chemotherapy, regardless of BRCA mutation status. It is also used as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer, showing clinical activity in these cases.12345
Is niraparib safe for humans?
Niraparib, a treatment for ovarian cancer, has been studied for safety, showing that most patients experience some side effects, with serious ones like low blood cell counts and high blood pressure in some cases. Dose adjustments are often needed to manage these side effects, and there is a small risk of developing blood disorders like leukemia.678910
How is the drug Niraparib unique in treating ovarian cancer?
Niraparib is unique because it is an oral PARP inhibitor that can be used as maintenance therapy for ovarian cancer patients regardless of their BRCA mutation status, unlike other treatments that often require specific genetic markers. It is also notable for its use in patients who have responded to platinum-based chemotherapy, offering a new option for those with recurrent or newly diagnosed ovarian cancer.1231112
What is the purpose of this trial?
Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.
Eligibility Criteria
This trial is for ovarian cancer patients in Saskatchewan who've responded to platinum-based chemotherapy and will undergo HRD testing. It's designed to help those with defective DNA repair mechanisms decide if PARPi therapy, specifically niraparib, is beneficial considering its impact on quality of life.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
HRD Testing
HRD testing is performed for ovarian cancer patients to determine eligibility for PARPi therapy
Treatment
Participants receive PARPi therapy, with a focus on evaluating treatment outcomes and quality of life
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
Treatment Details
Interventions
- Niraparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Saskatchewan
Lead Sponsor