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?
Patients must be able to understand the study, agree to participate and provide written, informed consent
Patients must be female and age >/= 18 years of age
Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment
Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT)
Patient's age is <18 years.
Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.
Patients with a known hypersensitivity to niraparib or any of its components
Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.
Single group
Niraparib
DrugNiraparib (Zejula) will be administered as an oral treatment once daily (continuously in a 28-day cycle). Niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles (28-days each cycle), if tolerated, the dose will be increased to 200 mg PO daily for the third and fourth cycle.
Incidence of thrombocytopenia
Incidence of thrombocytopenia \<100 x 109/L requiring a treatment interruption
Incidence of dose reduction due to thrombocytopenia
Incidence of discontinuation due to thrombocytopenia
Incidence of other hematologic toxicity
Incidence of dose reduction due to other hematologic toxicity
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Sunnybrook Health Sciences Centre
Lead sponsor
GlaxoSmithKline
Collaborator
