Real-life Use of Niraparib in a Patient Access Program in Norway
1 other identifier
observational
106
1 country
1
Brief Summary
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2020
CompletedFirst Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedMarch 8, 2021
March 1, 2021
3 years
January 27, 2021
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Time to 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
Time to progression assesed by 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
Type of subsequent chemotherapy if applicable
Through study completion, an average of 15 months
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Through study completion, an average of 15 months
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
Through study completion, an average of 15 months
- +4 more secondary outcomes
Interventions
Niraparib provided through the patient access program
Eligibility Criteria
Patients with relapsed ovarian, fallopian tube or peritoneum cancer in response to platinum based chemotherapy
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kristina Lindemannlead
- University Hospital of North Norwaycollaborator
- St. Olavs Hospitalcollaborator
- Haukeland University Hospitalcollaborator
- Sorlandet Hospital HFcollaborator
Study Sites (1)
Oslo University Hospital (OUH)
Oslo, 0379, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Lindemann, MD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Prof. Kristina Lindemann
Study Record Dates
First Submitted
January 27, 2021
First Posted
March 8, 2021
Study Start
July 31, 2017
Primary Completion
August 3, 2020
Study Completion
August 3, 2020
Last Updated
March 8, 2021
Record last verified: 2021-03