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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04785716
Study type	Observational
Source	Oslo University Hospital
Contact
Status	Completed
Phase
Start date	July 31, 2017
Completion date	August 3, 2020

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