Real-life Use of Niraparib in a Patient Access Program in Norway

Study Overview
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Brief Summary
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Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.

Detailed Description
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Poly (ADP-ribose) polymerase (PARP) inhibitors have emerged as new treatment options in ovarian cancer. While there is now also evidence for the efficacy in the first line setting, they were initially studied in recurrent disease both as maintenance after chemotherapy but also as treatment on its own. The NOVA study was conducted in the maintenance setting of patients with recurrent high-grade serous ovarian-, tube or peritoneal cancer who had responded to platinum-based chemotherapy. In 2017 Tesaro opened an individual patient access program in Norway, and in July 2017 the first Norwegian patient was enrolled. We performed a retrospective observational study of patients treated with niraparib in the individual patient access program in Norway. The objective of the study is to provide preliminary efficacy and safety data in a rather unselected population of non-gBRCA patients with recurrent ovarian-, tube-, or peritoneal cancer.

Official Title
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Real-life Use of Niraparib in a Patient Access Program in Norway

Conditions
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Ovarian Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: Niraparib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients enrolled in the individual patient access program since 2017. Patients who have received at least one dose of niraparib will be included. Patients will be identified and recruited from the following participating sites: Oslo University Hospital, Haukeland University Hospital, Stavanger University Hospital, St. Olavs Hospital, University Hospital of Northern Norway and Sørlandet sykehus.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Niraparib|Niraparib provided through the patient access program|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first subsequent treatment | Date of start of niraparib to start date of subsequent treatment | Through study completion, an average of 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Date of start niraparib to date of investigator assessed progression | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18.5 months | 
| Time to progression assesed by CA-125 | Date of start niraparib to date of 2xUNL CA-125 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18.5 months | 
| Type of subsequent chemotherapy if applicable | Type of subsequent chemotherapy | Through study completion, an average of 15 months | 
| Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR | Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR | Through study completion, an average of 15 months | 
| Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity | Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity | Through study completion, an average of 15 months | 
| Frequency of dose interruptions | Frequency of dose interruptions | Through study completion, an average of 15 months | 
| Frequency of dose reductions | Frequency of dose reductions | Through study completion, an average of 15 months | 
| Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other) | Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other) | Through study completion, an average of 15 months | 
| Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized) | Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized) | Through study completion, an average of 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poly(ADP-ribose) Polymerase Inhibitors, real life data, ovarian cancer, niraparib