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

March 2, 2021 updated by: Kristina Lindemann
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0379
        • Oslo University Hospital (OUH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsed ovarian, fallopian tube or peritoneum cancer in response to platinum based chemotherapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first subsequent treatment
Time Frame: Through study completion, an average of 15 months
Date of start of niraparib to start date of subsequent treatment
Through study completion, an average of 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 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
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
Time to progression assesed by CA-125
Time Frame: 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
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
Type of subsequent chemotherapy if applicable
Time Frame: Through study completion, an average of 15 months
Type of subsequent chemotherapy
Through study completion, an average of 15 months
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Time Frame: 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
Time Frame: 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
Frequency of dose interruptions
Time Frame: Through study completion, an average of 15 months
Frequency of dose interruptions
Through study completion, an average of 15 months
Frequency of dose reductions
Time Frame: Through study completion, an average of 15 months
Frequency of dose reductions
Through study completion, an average of 15 months
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Time Frame: Through study completion, an average of 15 months
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Through study completion, an average of 15 months
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Time Frame: Through study completion, an average of 15 months
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Through study completion, an average of 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristina Lindemann

Collaborators

University Hospital of North Norway
Haukeland University Hospital
Sorlandet Hospital HF
St. Olavs Hospital

Investigators

  • Principal Investigator: Kristina Lindemann, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 31, 2017

Primary Completion (ACTUAL)

August 3, 2020

Study Completion (ACTUAL)

August 3, 2020

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 62008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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