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Completed

NCT Number: NCT04785716

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

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital (OUH)

Oslo, 0379, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Niraparib

Drug

Niraparib provided through the patient access program

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Type of subsequent chemotherapy if applicable

    Time frame: Through study completion, an average of 15 months

    Type of subsequent chemotherapy

  4. 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

  5. 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

  6. Frequency of dose interruptions

    Time frame: Through study completion, an average of 15 months

    Frequency of dose interruptions

  7. Frequency of dose reductions

    Time frame: Through study completion, an average of 15 months

    Frequency of dose reductions

  8. 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)

  9. 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)

Sponsors and collaborators

Lead sponsor

Kristina Lindemann

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2021
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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