Overview
Sponsor-declared trial summary
Patients with high-grade serous epithelial ovarian, tubal or primary peritoneal cancers
Determination of the existence of links between patient-specific clinical/biological/therapeutic covariates and/or pharmacokinetic parameters of niraparib on the occurrence of hematological and/or renal toxicity(s) when used within the framework of its Marketing Authorization or ATU at 300 mg/day or at 200 mg/day in a …
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 5 May 2021 → 17 Apr 2025
- Decision date (initial)
- 2024-07-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513856-14-00
- EudraCT number
- 2020-005918-17
- ClinicalTrials.gov
- NCT04861181
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
Determination of the existence of links between patient-specific clinical/biological/therapeutic covariates and/or pharmacokinetic parameters of niraparib on the occurrence of hematological and/or renal toxicity(s) when used within the framework of its Marketing Authorization or ATU at 300 mg/day or at 200 mg/day in a reduced dose commonly prescribed, as maintenance treatment for high-grade serous ovarian cancer BRCA mutated or not.
Secondary objectives 4
- Determination of clinical/biological/therapeutic and dietary covariates influencing the pharmacokinetic parameters of niraparib
- Determination of the existence of a link between pharmacokinetic parameters and effectiveness of niraparib
- Development of a prognostic algorithm for individual adjustment of niraparib doses with a view to optimizing the benefit/risk ratio.
- Assessment of the impact of toxicities on quality of life (QLQ-OV28 scale)
Conditions and MedDRA coding
Patients with high-grade serous epithelial ovarian, tubal or primary peritoneal cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Niraparib Prospective, single-center, multi-site study
|
Not Applicable | None | Niraparib: Pharmacokinetics, Dosage of Niraparib 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. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Women aged over 18
- Histologically proven high grade serous epithelial ovarian, tubal or primary peritoneal cancer
- Patient who has already received 4 to 6 courses of platinum-based chemotherapy and for whom there is an indication for maintenance treatment with niraparib at a standard dose of 300 mg/day, or at a reduced dose of 200 mg/day at investigator's choice
- Initial glomerular filtration rate according to CKD-EPI formula adjusted for cystatin C ≥ 30ml/min/1.73m2 ((https://www.kidney.org/professionals/kdoqi/gfr_calculator)
- Normal liver function with bilirubinemia < 1.5N
- Interval of 6 to 8 weeks between the last course of platinum-based chemotherapy and the start of treatment with niraparib
- For women of childbearing age: contraception deemed effective during treatment and up to 6 months after stopping treatment (hormonal contraception inhibiting ovulation (estrogen + progesterone or progesterone alone), IUD, tubal ligation, abstinence sexual, vasectomy spouse).
- Patient having been informed and having given signed informed consent
- Patient affiliated to a social security scheme or beneficiary of such a scheme
Exclusion criteria 5
- Minor patients
- Pregnant or breastfeeding patients
- Patients unable to understand the protocol, or under guardianship-curatorship
- Low grade carcinoma
- Hypersensitivity to the active substance of niraparib or one of these excipients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Identification of clinical/biological/pharmacokinetic/therapeutic factors leading to hematological and/or renal toxicology(s).
Secondary endpoints 4
- Relation of the average pharmacokinetic parameters observed in patients according to the clinical/biological/therapeutic and dietary parameters studied.
- Relationship between the pharmacokinetic parameters measured and the PFS at 24 months.
- Creation of predictive models using logistic models or PK-PD models with direct or indirect effects.
- Measurement of quality of life and correlation with observed toxicities.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5625301 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 23100 mg milligram(s)
- Max treatment duration
- 77 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XK02 — -
- Marketing authorisation
- EU/1/17/1235/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr YOU
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr YOU
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 42 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2021-05-05 | 2025-04-17 | 2021-05-05 | 2023-05-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | France | Acceptable 2024-07-10
|
2024-07-10 |