NCT04785716

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Kristina Lindemann · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Ovarian Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib provided through the patient access program

Timeline

• Start date: 2017-07-31
• Primary completion: 2020-08-03
• Completion: 2020-08-03
• First posted: 2021-03-08
• Last updated: 2021-03-08

Locations

1 site across 1 country: Norway