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

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ClinicalTrials.gov Identifier: NCT03752216
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Niraparib Phase 4

Detailed Description:
The aim of NiQoLe 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 data 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2021


Arm Intervention/treatment
Experimental: NIRAPARIB
Oral Niraparib Daily
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.





Primary Outcome Measures :
  1. Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction). [ Time Frame: 3 months ]
    Evaluate treatment toxicities


Secondary Outcome Measures :
  1. Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue) [ Time Frame: Up to 18 months. ]
    Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)

  2. Self-reported symptoms and side effects with the NCI PRO-CTCAE [ Time Frame: Up to 18 months. ]
    Self-reported symptoms and side effects

  3. Reasons of the dose modification of Niraparib [ Time Frame: Up to 18 months. ]
    Reasons of the dose modification of Niraparib

  4. General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General) [ Time Frame: Up to 18 months. ]
    Functional Assessment of Cancer Therapy General questionnaire (score range from 0 [worse outcome] to 108 [better outcome])

  5. Pain related to the treatment by Visual Analogic Scale (VAS) [ Time Frame: Up to 18 months. ]
    Score range from 0 [worse outcome] to 10 [better outcome])

  6. Side effects of interest (HTA, anemia, thrombocytopenia) [ Time Frame: Up to 18 months. ]
    Side effects of interest (HTA, anemia, thrombocytopenia)

  7. Duration of Niraparib treatment [ Time Frame: Up to 18 months. ]
    From the start of Niraparib until progression or unacceptable toxicity.

  8. Time to first subsequent line of anti-cancer therapy [ Time Frame: Up to 18 months. ]
    From the stop of Niraparib to the first subsequent line of anti-cancer therapy.

  9. Overall response rate [ Time Frame: Up to 18 months. ]
    Overall response rate

  10. Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire [ Time Frame: At the inclusion visit ]
    FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)

  11. Plasma level of Niraparib before Niraparib administration [ Time Frame: Day 8 ]
    residual dosage of Niraparib

  12. Plasma level of Niraparib before Niraparib administration [ Time Frame: 3 months ]
    residual dosage of Niraparib

  13. Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome]) [ Time Frame: Up to 6 months. ]
    Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients must be ≥ 18 years of age.
  • Signed informed consent and ability to comply with treatment and follow-up.
  • Patients with histologically proved high grade epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcinoma.
  • Patients who relapse at least 6 months after the last dose of platine based chemotherapy (with no limitation of numbers of previous lines of chemotherapy).
  • Platine sensitive patients with a complete response or partial response after a line of platine based chemotherapy.
  • Participant must have adequate organ function
  • Patients with an indication of maintenance by Niraparib after platine based chemotherapy according to the labelling.
  • 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.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of Niraparib.
  • 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 non-childbearing potential.
  • Participant must agree to not breastfeed during the study or for 1 month after the last dose of Niraparib.

Exclusion Criteria:

  • Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
  • Participant must not be simultaneously enrolled in any interventional clinical trial.
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • 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.
  • Participant last treatment with platinum-based chemotherapy was ≥ 12 weeks from initiation of protocol therapy
  • 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. - - - - -
  • Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  • Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  • 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.
  • Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • 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.
  • Participant must not be deprived of liberty, under guardianship or under trusteeship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752216


Contacts
Contact: Magali CESANA +33(1)42348323 mcesana@arcagy.org

Locations
France
Institut Sainte-Catherine Not yet recruiting
Avignon, France, 84918
Contact: Julien GRENIER         
CHRU Jean Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Elsa KALBACHER         
Clinique Tivoli Not yet recruiting
Bordeaux, France, 33000
Contact: Delphine GARBAY-DECOOPMAN         
Institut Bergonié Not yet recruiting
Bordeaux, France, 33076
Contact: Camille CHAKIBA         
Hôpital Fleyriat Not yet recruiting
Bourg-en-bresse, France, 01012
Contact: Hubert ORFEUVRE         
Centre François Baclesse Not yet recruiting
Caen, France, 14000
Contact: Pierre-Emmanuel BRACHET         
ROC 37 Société de Recherche Oncologique Clinique 37 Not yet recruiting
Chambray-lès-Tours, France, 37170
Contact: Pierre COMBE         
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Marie Ange MOURET-REYNIER         
Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: Isabelle RAY-COQUARD         
Hôpital Privé Jean Mermoz Not yet recruiting
Lyon, France, 69373
Contact: Olfa DERBEL         
Institut Paoli Calmettes Not yet recruiting
Marseille, France, 13009
Contact: Magali PROVANSAL         
CH Mont-de-Marsan Not yet recruiting
Mont-de-marsan, France, 40024
Contact: Jérôme DAUBA         
ICM Val d'Aurelle Not yet recruiting
Montpellier, France, 34298
Contact: Michel FABBRO         
ORACLE - Centre d'Oncologie de Gentilly Not yet recruiting
Nancy, France, 54100
Contact: Célia ROEMER-BECUWE         
Centre Antoine Lacassagne Not yet recruiting
Nice, France, 06189
Contact: Philippe FOLLANA         
Centre ONCOGARD - Institut de Cancérologie du Gard Not yet recruiting
Nimes, France, 30029
Contact: Eric LEGOUFFE         
Hôpital Cochin Not yet recruiting
Paris, France, 75014
Contact: Jérôme ALEXANDRE         
Groupe Hospitalier Diaconesses-Croix Saint Simon Not yet recruiting
Paris, France, 75020
Contact: Frédéric SELLE         
Centre CARIO - HPCA Not yet recruiting
Plérin, France, 22190
Contact: Anne-Claire HARDY-BESSARD         
Clinique Mutualiste de l'Estuaire Not yet recruiting
Saint-nazaire, France, 44600
Contact: Valérie DELECROIX         
Institut de Cancérologie Lucien Neuwirth Not yet recruiting
Saint-Priest-en-Jarez, France, 42271
Contact: Olivier COLLARD         
Hôpitaux Universitaires de Strasbourg Not yet recruiting
Strasbourg, France, 67000
Contact: Jean-Emmanuel KURTZ         
Institut Claudius Regaud Not yet recruiting
Toulouse, France, 31059
Contact: Laurence GLADIEFF         
Clinique Pasteur - ONCOSUD Not yet recruiting
Toulouse, France, 31076
Contact: Raymond DESPAX         
Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Fanny POMMERET         
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Tesaro, Inc.
Investigators
Principal Investigator: Florence JOLY, MD, PhD Centre François Baclesse 3, avenue du Général Harris 14076 CAEN

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT03752216     History of Changes
Other Study ID Numbers: GINECO-OV239B
2018-002274-44 ( EudraCT Number )
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ARCAGY/ GINECO GROUP:
Ovarian Cancer
Anti-PARP (poly-ADP ribose polymerase)
Late Relapse

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents