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

Kristina Lindemann

Status: Completed

Conditions: Peritoneal Cancer; Ovarian Cancer

Treatments: Drug: Niraparib

Study type: Observational

Funder types: Other

Identifiers

NCT04785716

REK 62008

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.