Clinical trial NCT04785716: Real-life Use of Niraparib in a Patient Access Program in Norway
Official title: Real-life Use of Niraparib in a Patient Access Program in Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Peritoneal Cancer
Keywords: Poly(ADP-ribose) Polymerase Inhibitors
real life data
ovarian cancer
niraparib
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: St. Olavs Hospital
name: Haukeland University Hospital
name: Sorlandet Hospital HF
First posted: 2021-03-08
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed ovarian, fallopian tube or peritoneum cancer in response to platinum based chemotherapy

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Time to first subsequent treatment
timeFrame: Through study completion, an average of 15 months
Secondary outcomes:
measure: Time to progression
timeFrame: 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
measure: Time to progression assesed by CA-125
timeFrame: 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
measure: Type of subsequent chemotherapy if applicable
timeFrame: Through study completion, an average of 15 months
measure: Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
timeFrame: Through study completion, an average of 15 months
measure: Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
timeFrame: Through study completion, an average of 15 months
measure: Frequency of dose interruptions
timeFrame: Through study completion, an average of 15 months
measure: Frequency of dose reductions
timeFrame: Through study completion, an average of 15 months
measure: Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
timeFrame: Through study completion, an average of 15 months
measure: Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
timeFrame: Through study completion, an average of 15 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital (OUH)
Study officials:
affiliation: Oslo University Hospital
name: Kristina Lindemann, MD
role: PRINCIPAL_INVESTIGATOR
References: