Ovarian CancerNCT04785716
Real-life Use of Niraparib in a Patient Access Program in Norway
An observational study of Ovarian Cancer and Peritoneal Cancer, run by Kristina Lindemann at 1 site in Norway.
Trial summary
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer
- What is being tested?
- Niraparib
- How many people
- 106 participants
- Where
- 1 siteNorway
- Study dates
- 31 Jul 2017to 3 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with relapsed ovarian, fallopian tube or peritoneum cancer in response to platinum based chemotherapy
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.
Read the 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.
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Being tested
- Niraparib
- Keywords
- Poly(ADP-ribose) Polymerase Inhibitors, real life data, ovarian cancer, niraparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib provided through the patient access program
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first subsequent treatment
Date of start of niraparib to start date of subsequent treatment
Measured: Through study completion, an average of 15 months
Secondary outcomes (9)
Time to progression
Date of start niraparib to date of investigator assessed progression
Measured: 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
Date of start niraparib to date of 2xUNL CA-125
Measured: 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
Type of subsequent chemotherapy
Measured: Through study completion, an average of 15 months
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Measured: Through study completion, an average of 15 months
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
Measured: Through study completion, an average of 15 months
Frequency of dose interruptions
Frequency of dose interruptions
Measured: Through study completion, an average of 15 months
Frequency of dose reductions
Frequency of dose reductions
Measured: Through study completion, an average of 15 months
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Measured: Through study completion, an average of 15 months
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Measured: Through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start31 Jul 2017
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Lindemann
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital, Sorlandet Hospital HF
- Responsible party
- Sponsor-investigator, Kristina Lindemann, Oslo University Hospital
- Investigators
- Kristina Lindemann, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785716
- Sponsor's protocol ID
- REK 62008
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Use of Niraparib in a Patient Access Program in Norway
- ClinicalTrials.gov ID
- NCT04785716
- Acronym / sponsor ID
- REK 62008
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Keywords
- Poly(ADP-ribose) Polymerase Inhibitors, real life data, ovarian cancer, niraparib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Kristina LindemannUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital, Sorlandet Hospital HF
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with relapsed ovarian, fallopian tube or peritoneum cancer in response to platinum based chemotherapy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibNiraparib provided through the patient access program | Drug | – |
Primary outcome
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
9 secondary outcomes
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
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
Type of subsequent chemotherapy if applicable
Time frame: 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
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
Frequency of dose interruptions
Time frame: Through study completion, an average of 15 months
Frequency of dose reductions
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Lindemann, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Peritoneal Cancer, run by Kristina Lindemann at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first subsequent treatment (time frame: Through study completion, an average of 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.