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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785716
• Other study ID #: REK 62008
• Status: Completed
• Start date: July 31, 2017
• Est. completion date: August 3, 2020

Study information

• Verified date: March 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• Niraparib
Niraparib provided through the patient access program

Locations

Country	Name	City	State
Norway	Oslo University Hospital (OUH)	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Kristina Lindemann	Haukeland University Hospital, Sorlandet Hospital HF, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Type of subsequent chemotherapy if applicable	Type of subsequent chemotherapy	Through study completion, an average of 15 months
Secondary	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
Secondary	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
Secondary	Frequency of dose interruptions	Frequency of dose interruptions	Through study completion, an average of 15 months
Secondary	Frequency of dose reductions	Frequency of dose reductions	Through study completion, an average of 15 months
Secondary	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
Secondary	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