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

Ovarian Cancer Clinical Trial

— NiQoLe  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752216
• Other study ID #: GINECO-OV239B
• Secondary ID: 2018-002274-44
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2019
• Est. completion date: December 13, 2022

Study information

• Verified date: November 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 13, 2022
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 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

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Niraparib
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.

Locations

Country	Name	City	State
France	Sainte-Catherine Institut du Cancer Avignon-Provence	Avignon
France	Centre Hospitalier de la Côte Basque	Bayonne
France	CHRU Jean Minjoz	Besançon
France	Clinique Tivoli	Bordeaux
France	Institut Bergonié	Bordeaux
France	Hôpital Fleyriat	Bourg-en-bresse
France	Centre François Baclesse	Caen
France	Medipole de Savoie	Challes-les-Eaux
France	SASU Centre d'Oncologie et Radiothérapie 37	Chambray-lès-Tours
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Georges François Leclerc	Dijon
France	Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard	Grenoble
France	Les Hôpitaux de Chartres - Hôpital Louis Pasteur	Le Coudray
France	Hôpital Privé Jean Mermoz	Lyon
France	ICM Val d'Aurelle	Montpellier
France	Médipôle de NANCY / Centre d'Oncologie de Gentilly	Nancy
France	Centre Antoine Lacassagne	Nice
France	Centre ONCOGARD - Institut de Cancérologie du Gard	Nimes
France	Centre Hospitalier Régional d'Orléans	Orléans
France	Groupe Hospitalier Diaconesses-Croix Saint Simon	Paris
France	Hôpital Cochin	Paris
France	Centre CARIO - HPCA	Plérin
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Institut du Cancer Courlancy	Reims
France	Centre Hospitalier Saint-Malo	Saint-Malo
France	Clinique Mutualiste de l'Estuaire	Saint-nazaire
France	CHU de Saint-Etienne - Pôle de Cancérologie	Saint-Priest-en-Jarez
France	Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe	Strasbourg
France	Clinique Pasteur	Toulouse
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Tesaro, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).	Evaluate treatment toxicities	3 months
Secondary	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)	Up to 18 months.
Secondary	Self-reported symptoms and side effects with the NCI PRO-CTCAE	Self-reported symptoms and side effects	Up to 18 months.
Secondary	Reasons of the dose modification of Niraparib	Reasons of the dose modification of Niraparib	Up to 18 months.
Secondary	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])	Up to 18 months.
Secondary	Pain related to the treatment by Visual Analogic Scale (VAS)	Score range from 0 [worse outcome] to 10 [better outcome])	Up to 18 months.
Secondary	Side effects of interest (HTA, anemia, thrombocytopenia)	Side effects of interest (HTA, anemia, thrombocytopenia)	Up to 18 months.
Secondary	Duration of Niraparib treatment	From the start of Niraparib until progression or unacceptable toxicity.	Up to 18 months.
Secondary	Time to first subsequent line of anti-cancer therapy	From the stop of Niraparib to the first subsequent line of anti-cancer therapy.	Up to 18 months.
Secondary	Overall response rate	Overall response rate	Up to 18 months.
Secondary	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)	At the inclusion visit
Secondary	Plasma level of Niraparib before Niraparib administration	residual dosage of Niraparib	Day 8
Secondary	Plasma level of Niraparib before Niraparib administration	residual dosage of Niraparib	3 months
Secondary	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])	Up to 6 months.