Real-life Use of Niraparib in a Patient Access Program in Norway
Study Details
Study Description
Brief Summary
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Time to first subsequent treatment [Through study completion, an average of 15 months]
Date of start of niraparib to start date of subsequent treatment
Secondary Outcome Measures
- Time to 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]
Date of start niraparib to date of investigator assessed progression
- Time to progression assesed by 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]
Date of start niraparib to date of 2xUNL CA-125
- Type of subsequent chemotherapy if applicable [Through study completion, an average of 15 months]
Type of subsequent chemotherapy
- Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR [Through study completion, an average of 15 months]
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
- Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity [Through study completion, an average of 15 months]
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
- Frequency of dose interruptions [Through study completion, an average of 15 months]
Frequency of dose interruptions
- Frequency of dose reductions [Through study completion, an average of 15 months]
Frequency of dose reductions
- Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other) [Through study completion, an average of 15 months]
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
- Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized) [Through study completion, an average of 15 months]
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients enrolled in the individual patient access program since 2017.
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Patients who have received at least one dose of niraparib will be included.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Oslo University Hospital (OUH) | Oslo | Norway | 0379 |
Sponsors and Collaborators
- Kristina Lindemann
- University Hospital of North Norway
- St. Olavs Hospital
- Haukeland University Hospital
- Sorlandet Hospital HF
Investigators
- Principal Investigator: Kristina Lindemann, MD, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REK 62008