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 : Completed
First Posted : November 23, 2018
Last Update Posted : December 23, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Niraparib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 3, 2019|
|Actual Primary Completion Date :||August 18, 2021|
|Actual Study Completion Date :||December 13, 2022|
Oral Niraparib Daily
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.
- 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
- 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)
- Self-reported symptoms and side effects with the NCI PRO-CTCAE [ Time Frame: Up to 18 months. ]Self-reported symptoms and side effects
- Reasons of the dose modification of Niraparib [ Time Frame: Up to 18 months. ]Reasons of the dose modification of Niraparib
- 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])
- 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])
- Side effects of interest (HTA, anemia, thrombocytopenia) [ Time Frame: Up to 18 months. ]Side effects of interest (HTA, anemia, thrombocytopenia)
- Duration of Niraparib treatment [ Time Frame: Up to 18 months. ]From the start of Niraparib until progression or unacceptable toxicity.
- 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.
- Overall response rate [ Time Frame: Up to 18 months. ]Overall response rate
- 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)
- Plasma level of Niraparib before Niraparib administration [ Time Frame: Day 8 ]residual dosage of Niraparib
- Plasma level of Niraparib before Niraparib administration [ Time Frame: 3 months ]residual dosage of Niraparib
- 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|
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
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.
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
|Principal Investigator:||Florence JOLY, MD, PhD||Centre François Baclesse 3, avenue du Général Harris 14076 CAEN|
|Responsible Party:||ARCAGY/ GINECO GROUP|
|Other Study ID Numbers:||
2018-002274-44 ( EudraCT Number )
|First Posted:||November 23, 2018 Key Record Dates|
|Last Update Posted:||December 23, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anti-PARP (poly-ADP ribose polymerase)
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Molecular Mechanisms of Pharmacological Action