Alternative Dosing of Niraparib for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are:What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients receiving certain prohibited medications. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is niraparib generally safe for humans?
Niraparib is generally well tolerated in humans, with most side effects being related to blood cell counts, such as low platelet levels (thrombocytopenia), low red blood cell levels (anemia), and low white blood cell levels (neutropenia). These side effects are usually manageable with dose adjustments or temporary stopping of the medication.12345
How is the drug Niraparib unique in treating ovarian cancer?
Niraparib is unique because it is a PARP inhibitor that can be used for maintenance therapy in ovarian cancer patients regardless of their BRCA mutation or homologous recombination deficiency status, offering a treatment option for those who may not have other maintenance therapies available. It is taken orally and has a manageable side effect profile, with dose adjustments based on weight and platelet count to improve tolerability.12346
What data supports the effectiveness of the drug Niraparib for ovarian cancer?
Who Is on the Research Team?
Dr. Allan Covens, MD
Principal Investigator
Sunnybrook Research Institute
Are You a Good Fit for This Trial?
This trial is for women over 18 with newly diagnosed high-grade ovarian cancer who've completed certain chemotherapies. They must be post-menopausal, surgically sterilized, or use contraception. Exclusions include pregnancy, previous severe reactions to niraparib or PARP inhibitors, and certain health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral niraparib in a dose escalation design starting at 100 mg PO daily for the first two cycles, then 200 mg PO daily for the third and fourth cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival at 24 months.
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
Niraparib is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School