Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian CancerPhase 4NIRAPKNCT04861181
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
A Phase 4 study testing Pharmacokinetics, Dosage of Niraparib in people with Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries. Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
- What is being tested?
- Pharmacokinetics, Dosage of Niraparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2021to 17 Apr 2025
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Study Information and written informed consent
- Social Security Affiliation
- Patient > 18 years old.
- Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/day)
- Glomerular filtration rate with standardized serum creatinine values using CKD-EPI formula ≥ 30ml/min/1.73m2 (https://www.kidney.org/professionals/kdoqi/gfr_calculator)
- Normal liver function with bilirubin < 1.5N
- 6-8 weeks break between last chemotherapy and Niraparib treatment initiation.
- Patient with an effective birth control
Who cannot join
- Minor patient
- Patient not able to understand the aim of the study or under curatorship
- Low grade carcinoma
- Pregnant or breastfeeding patient
- Hypersensivity to an active substance present in niraparib
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lyon sud, Institut de Cancérologie des Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment (300mg or 200 mg/Day) for Ovarian Cancer Patients.
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries.
Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor.
Read more
A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy. There is however a high rate of relapse/recurrence (disease progression ranging from 10 to 26 months).
Poly ADP ribose polymerase inhibitors (PARPi), a new class of therapeutic molecules have recently revolutionized this paradigm, demonstrating progression-free survival (PFS) advantages in several trials.
The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line, irrespectively of patients' BRCA-mutated gene or HR status.
Since, results of the Phase III trial PRIMA, have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment, for adult patients with platinum-sensitive, relapsed, high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy, irrespectively of their BRCA-mutated gene or HR status.
However, despite its high therapeutic potential, Niraparib at standard dose (200 or 300mg/day) is known to lead to hematologic toxicity and/or nephrotoxicity. This was demonstrated during the NOVA trial (the dose of Niraparib having to be reduced in 80% of the patients to reduce toxicity).
A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight <77kg and an initial platelet count <175 G/L. However, it seems more complex as 50% of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia. Same for platelet count. Creatinine clearance below 60ml/min and an hypoalbuminemia <35 g/l have also been identified in another study as predictive factors to thrombocytopenia.
The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood.
The aim of our study is therefore to better identify which clinical, biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment (200 or 300mg/day) for ovarian cancer patients.
- Conditions
- Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
- Being tested
- Pharmacokinetics, Dosage of Niraparib
- Keywords
- Niraparid, Pharmacokinetic, Hematologic toxicity, Nephrotoxicity, Thrombocytopenia, Maintenance treatment, Ovarian cancer, Predictive factors
- Medical subject headings
- Recurrence, Thrombocytopenia, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetics, Dosage of NiraparibBiological
The biological samples collected during the NIRAPK study will be blood only. The complete biological work-up will be processed in the same way as the usual routine care procedure. Serum niraparib will be measured over 3 courses just prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetics, Dosage of Niraparib | Experimental | Patients received 3 cycles of Niraparib (200 mg or 300 mg/day). Each cycle lasts 28 days. Serum niraparib assays will be performed for all patients over 3 courses immediately prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15. Receives: Biological: Pharmacokinetics, Dosage of Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of metrics (clinical, biological, pharmacokinetic) that are considered as toxicity induction causes (hematological toxicity or nephrotoxicity)
Blood will be sampled at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and based on the obtained results, it will be seek if a link can be established between the clinical, biological and pharmacokinetic metrics and the observed toxicity.
Measured: Month 10; after all the blood sample collection is achieved for all included patients.
Secondary outcomes (6)
Determination of the average pharmacokinetic metrics observed in our study panel patients.
Blood will be sampled at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and based on the obtained results, the average metrics of pharmacokinetic parameters will be determined.
Measured: Month 10; after all the blood sample collection is achieved for all included patients..
Relationship between the pharmacokinetic metrics and the PFS at 24 months.
Blood will be sampled at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and based on the obtained results, it will be determined if a link can be established between the pharmacokinetic metrics and the PFS at 24 months
Measured: Month 34; after last patient inclusion (Month 10) + 24 months.
Relationship between the quality of life and the observed toxicity assessed by the "EORTC OVARIAN" questionnaire
Analysis of quality of life by "QLQ OV28" questionnaire score collected at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and observed toxicity.
Measured: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Charlson Score" questionnaire
Analysis of quality of life by "Charlson Score" questionnaire score collected at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and observed toxicity.
Measured: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Assessment of polymedication" questionnaire
Analysis of quality of life by "Assessment of polymedication" questionnaire score collected at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and observed toxicity.
Measured: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Recording of food intake and monitoring of eating habits" questionnaire
Analysis of quality of life by "Recording of food intake and monitoring of eating habits" questionnaire score collected at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and observed toxicity.
Measured: Month 10, after last patient enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start5 May 2021
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Why it stopped: End of inclusion period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861181
- Sponsor's protocol ID
- 69HCL20_0989
- Acronym
- NIRAPK
- Status last verified
- May 2025
- First submitted
- 20 Apr 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment (300mg or 200 mg/Day) for Ovarian Cancer Patients.
- ClinicalTrials.gov ID
- NCT04861181
- Acronym / sponsor ID
- NIRAPK / 69HCL20_0989
- Conditions
- Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
- Keywords
- Niraparid, Pharmacokinetic, Hematologic toxicity, Nephrotoxicity, Thrombocytopenia, Maintenance treatment, Ovarian cancer, Predictive factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of inclusion period.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 27 Apr 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.
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries.
Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor.
A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy. There is however a high rate of relapse/recurrence (disease progression ranging from 10 to 26 months).
Poly ADP ribose polymerase inhibitors (PARPi), a new class of therapeutic molecules have recently revolutionized this paradigm, demonstrating progression-free survival (PFS) advantages in several trials.
The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line, irrespectively of patients' BRCA-mutated gene or HR status.
Since, results of the Phase III trial PRIMA, have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment, for adult patients with platinum-sensitive, relapsed, high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy, irrespectively of their BRCA-mutated gene or HR status.
However, despite its high therapeutic potential, Niraparib at standard dose (200 or 300mg/day) is known to lead to hematologic toxicity and/or nephrotoxicity. This was demonstrated during the NOVA trial (the dose of Niraparib having to be reduced in 80% of the patients to reduce toxicity).
A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight <77kg and an initial platelet count <175 G/L. However, it seems more complex as 50% of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia. Same for platelet count. Creatinine clearance below 60ml/min and an hypoalbuminemia <35 g/l have also been identified in another study as predictive factors to thrombocytopenia.
The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood.
The aim of our study is therefore to better identify which clinical, biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment (200 or 300mg/day) for ovarian cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics, Dosage of Niraparib | Experimental | Biological: Pharmacokinetics, Dosage of NiraparibPatients received 3 cycles of Niraparib (200 mg or 300 mg/day). Each cycle lasts 28 days. Serum niraparib assays will be performed for all patients over 3 courses immediately prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient Study Information and written informed consent
- Social Security Affiliation
- Patient > 18 years old.
- Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/day)
- Glomerular filtration rate with standardized serum creatinine values using CKD-EPI formula ≥ 30ml/min/1.73m2 (https://www.kidney.org/professionals/kdoqi/gfr_calculator)
Key exclusion criteria (5 listed)
- Minor patient
- Patient not able to understand the aim of the study or under curatorship
- Low grade carcinoma
- Pregnant or breastfeeding patient
- Hypersensivity to an active substance present in niraparib
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 |
|---|---|---|
| Pharmacokinetics, Dosage of NiraparibThe biological samples collected during the NIRAPK study will be blood only. The complete biological work-up will be processed in the same way as the usual routine care procedure. Serum niraparib will be measured over 3 courses just prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15. | Biological | Pharmacokinetics, Dosage of Niraparib |
Primary outcome
Identification of metrics (clinical, biological, pharmacokinetic) that are considered as toxicity induction causes (hematological toxicity or nephrotoxicity)
Time frame: Month 10; after all the blood sample collection is achieved for all included patients.
Blood will be sampled at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 and based on the obtained results, it will be seek if a link can be established between the clinical, biological and pharmacokinetic metrics and the observed toxicity.
6 secondary outcomes
Determination of the average pharmacokinetic metrics observed in our study panel patients.
Time frame: Month 10; after all the blood sample collection is achieved for all included patients..
Relationship between the pharmacokinetic metrics and the PFS at 24 months.
Time frame: Month 34; after last patient inclusion (Month 10) + 24 months.
Relationship between the quality of life and the observed toxicity assessed by the "EORTC OVARIAN" questionnaire
Time frame: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Charlson Score" questionnaire
Time frame: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Assessment of polymedication" questionnaire
Time frame: Month 10, after last patient enrolment.
Relationship between the quality of life and the observed toxicity assessed by the "Recording of food intake and monitoring of eating habits" questionnaire
Time frame: Month 10, after last patient enrolment.
Results and safety
The study was stopped early (reason given: End of inclusion period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacokinetics, Dosage of Niraparib in people with Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 May 2025. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: End of inclusion period.). Results are not available in the source record.
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?
Identification of metrics (clinical, biological, pharmacokinetic) that are considered as toxicity induction causes (hematological toxicity or nephrotoxicity) (time frame: Month 10; after all the blood sample collection is achieved for all included patients.). 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 22 May 2025.