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Ovarian CancerPhase 4NiQoLeNCT03752216

NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.

A Phase 4 study testing Niraparib in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 30 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
30 sitesFrance
Study dates
3 Apr 2019to 13 Dec 2022
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

  • I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with histologically proved high grade epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcioma.
  • I-4 Platine sensitive and ovarian, fallopian or peritoneal cancer recurrent patients with a complete response or partial response after a line of platine based chemotherapy.
  • I-5 Participant must have adequate organ function, defined as follows:
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
Show all 16Show fewer
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN I-6 Patients with an indication of maintenance by Niraparib after platine based chemotherapy according to the labelling (see appendix 17).
  • I-7 As this study will include patients in France, a subject will be eligible in this study only if either affiliated to, or a beneficiary of, a social category.
  • I-8 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • I-9 Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  • I-10 Participant must agree to not donate blood during the study or for 90 days after the last dose of Niraparib.
  • I-11 Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 1 month after the last dose of study treatment, or is of nonchildbearing potential.
  • I-12 Participant must agree to not breastfeed during the study or for 1 month after the last dose of Niraparib.
  • I-13 Participant must have normal blood pressure or adequately treated and controlled hypertension

Who cannot join

  • E-1 Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
  • E-2 Participant must not be simultaneously enrolled in any interventional clinical trial.
  • E-3 Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • E-4 Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
  • E-5 Participant last treatment with platinum-based chemotherapy was ≥12 weeks from initiation of protocol therapy E-6 Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  • E-7 Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks NiQoLe - Study protocol - v3.0 on 08/10/2020 Page 10 on 109 N° EudraCT: 2018-002274-44 prior to initiating protocol therapy. E-8 Participant must not have received colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. E-9 Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. E-10 Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). E-11 Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. E-12 Participant must not be deprived of liberty, under guardianship or under trusteeship.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    Avignon, 84918

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • CHRU Jean Minjoz

    Besançon, 25030

  • Clinique Tivoli

    Bordeaux, 33000

  • Institut Bergonié

    Bordeaux, 33076

  • Hôpital Fleyriat

    Bourg-en-Bresse, 01012

  • Centre François Baclesse

    Caen, 14000

  • Medipole de Savoie

    Challes-les-Eaux, 73190

  • SASU Centre d'Oncologie et Radiothérapie 37

    Chambray-lès-Tours, 37170

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

    Grenoble, 38028

  • Les Hôpitaux de Chartres - Hôpital Louis Pasteur

    Le Coudray, 28630

  • Hôpital Privé Jean Mermoz

    Lyon, 69373

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Médipôle de NANCY / Centre d'Oncologie de Gentilly

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre ONCOGARD - Institut de Cancérologie du Gard

    Nîmes, 30029

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45000

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Diaconesses-Croix Saint Simon

    Paris, 75020

  • Centre CARIO - HPCA

    Plérin, 22190

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

  • Institut du Cancer Courlancy

    Reims, 51100

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44600

  • CHU de Saint-Etienne - Pôle de Cancérologie

    Saint-Priest-en-Jarez, 42271

  • Centre Hospitalier Saint-Malo

    St-Malo, 35400

  • Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe

    Strasbourg, 67200

  • Clinique Pasteur

    Toulouse, 31076

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

Official title: Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib in Maintenance After Platine-based Chemotherapy for Patients with Ovarian Cancer Late Relapse : the French GINECO - NiQoLe Study

This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.

Read the detailed description

The aim of NiQoLe, phase IV study is to evaluate tolerability of Niraparib and the management by the physicians of the side-effects in real life in France. The study will also generate complementary data of NOVA trial on longitudinal follow up of closed symptoms and side effects reported by the patients especially with the NCI PRO (Patient-Reported Outcome)-CTCAE system. Specific oncogeriatric data will be collected among on a subgroup of elderly patients.

Conditions
Ovarian Cancer
Being tested
Niraparib
Keywords
Ovarian Cancer, Anti-PARP (poly-ADP ribose polymerase), Late Relapse
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

    Two different doses of Niraparib can be administrated:

    For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules.

    For patient who had at baseline (T0) a body weight < 77 kg or a platelet count <150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules.

    Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.

Study groups in NCT03752216
Study groupRoleWhat they receive
NIRAPARIBExperimentalOral Niraparib Daily
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).

    Evaluate treatment toxicities

    Measured: 3 months

Secondary outcomes (13)

  1. Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)

    Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)

    Measured: Up to 18 months.

  2. Self-reported symptoms and side effects with the NCI PRO-CTCAE

    Self-reported symptoms and side effects

    Measured: Up to 18 months.

  3. Reasons of the dose modification of Niraparib

    Reasons of the dose modification of Niraparib

    Measured: Up to 18 months.

  4. General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)

    Functional Assessment of Cancer Therapy General questionnaire (score range from 0 [worse outcome] to 108 [better outcome])

    Measured: Up to 18 months.

  5. Pain related to the treatment by Visual Analogic Scale (VAS)

    Score range from 0 [worse outcome] to 10 [better outcome])

    Measured: Up to 18 months.

  6. Side effects of interest (HTA, anemia, thrombocytopenia)

    Side effects of interest (HTA, anemia, thrombocytopenia)

    Measured: Up to 18 months.

  7. Duration of Niraparib treatment

    From the start of Niraparib until progression or unacceptable toxicity.

    Measured: Up to 18 months.

  8. Time to first subsequent line of anti-cancer therapy

    From the stop of Niraparib to the first subsequent line of anti-cancer therapy.

    Measured: Up to 18 months.

  9. Overall response rate

    Overall response rate

    Measured: Up to 18 months.

  10. Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire

    FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)

    Measured: At the inclusion visit

  11. Plasma level of Niraparib before Niraparib administration

    residual dosage of Niraparib

    Measured: Day 8

  12. Plasma level of Niraparib before Niraparib administration

    residual dosage of Niraparib

    Measured: 3 months

  13. Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])

    Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])

    Measured: Up to 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start3 Apr 2019
  3. Primary completion18 Aug 2021
  4. Study completion13 Dec 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03752216
Sponsor's protocol ID
GINECO-OV239B
Other IDs
2018-002274-44, 2018
Acronym
NiQoLe
Status last verified
Dec 2024
First submitted
12 Nov 2018
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Joly F, Bazan F, Garbay D, Ouldbey Y, Follana P, Champeaux-Orange E, Legouffe E, Brachet PE, Spaeth D, Combe P, Hardy-Bessard AC, Selle F, Grenier J, Lebreton C, Derbel O, Bonnet E, Fournel P, Fernandez Diez Y, Delecroix V, Emambux S, Alexandre J, Grellety T, Mille D, Orfeuvre H, Favier C, Le Roux D, Mouret-Reynier MA, Quesada S, Kurtz JE. Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe). JNCI Cancer Spectr. 2025 Jan 3;9(1):pkae114. doi: 10.1093/jncics/pkae114.

    PubMed 39673810

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Niraparib in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 30 sites 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 16 inclusion and 6 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites 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 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?

Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction). (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03752216, which also lists 1 linked publication.

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 13 Dec 2024.

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