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

Sponsor
Kristina Lindemann (Other)
Overall Status
Completed
CT.gov ID
NCT04785716
Collaborator
University Hospital of North Norway (Other), St. Olavs Hospital (Other), Haukeland University Hospital (Other), Sorlandet Hospital HF (Other)
106
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36.1
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-life Use of Niraparib in a Patient Access Program in Norway
Actual Study Start Date :
Jul 31, 2017
Actual Primary Completion Date :
Aug 3, 2020
Actual Study Completion Date :
Aug 3, 2020

Outcome Measures

Primary Outcome Measures

  1. Time to first subsequent treatment [Through study completion, an average of 15 months]

    Date of start of niraparib to start date of subsequent treatment

Secondary Outcome Measures

  1. 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]

    Date of start niraparib to date of investigator assessed progression

  2. 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]

    Date of start niraparib to date of 2xUNL CA-125

  3. Type of subsequent chemotherapy if applicable [Through study completion, an average of 15 months]

    Type of subsequent chemotherapy

  4. Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR [Through study completion, an average of 15 months]

    Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR

  5. Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity [Through study completion, an average of 15 months]

    Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity

  6. Frequency of dose interruptions [Through study completion, an average of 15 months]

    Frequency of dose interruptions

  7. Frequency of dose reductions [Through study completion, an average of 15 months]

    Frequency of dose reductions

  8. Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other) [Through study completion, an average of 15 months]

    Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)

  9. Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized) [Through study completion, an average of 15 months]

    Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital (OUH) Oslo Norway 0379

Sponsors and Collaborators

  • Kristina Lindemann
  • University Hospital of North Norway
  • St. Olavs Hospital
  • Haukeland University Hospital
  • Sorlandet Hospital HF

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristina Lindemann, Associate Prof. Kristina Lindemann, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT04785716
Other Study ID Numbers:
  • REK 62008
First Posted:
Mar 8, 2021
Last Update Posted:
Mar 8, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kristina Lindemann, Associate Prof. Kristina Lindemann, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2021