Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
27
Countries
6
Sites
9
Advanced ovarian, breast, or prostate cancer
To evaluate the long-term safety and tolerability of niraparib
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2021 → ongoing
- Decision date (initial)
- 2023-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- GSK, United Kingdom
External identifiers
- EU CT number
- 2023-506618-29-00
- EudraCT number
- 2020-002667-53
- ClinicalTrials.gov
- NCT04641247
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Others
To evaluate the long-term safety and tolerability of niraparib
Secondary objectives 1
- No secondary objectives will be evaluated in this study
Conditions and MedDRA coding
Advanced ovarian, breast, or prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Subject is able to understand the study procedures and agrees to participate in the study by providing written informed consent. 2. Subject is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. 3. Subject is currently receiving treatment with niraparib (as monotherapy or in combination) in a GSK/TESARO-sponsored study that has fulfilled the requirements for the primary objective. 4. Subject is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements. 5. Subjects of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug. -Male subjects must use a condom and must not donate sperm during study treatment with niraparib and for 90 days after receiving the last dose of Study Drug.
Exclusion criteria 1
- 1. Subject has been permanently discontinued from niraparib treatment in the parent study for any reason. 2. Subject currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Subjects meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. 3. Subject is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Subject is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology, chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (...).
- 2. (excluding any study drugs used in the parent study) All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedRA) coding system outlined in the statistical analysis plan.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
Niraparib Tosilate Monohydrate
PRD10571865 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
PRD7912218 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Substance synonyms
- NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XK02 — -
- Marketing authorisation
- EU/1/17/1235/003
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical image Niraparib Tablets, 100 mg used in clinical studies are identical to the commercial Zejula Tablets, 100 mg except the tablets are not debossed to maintain the blind in clinical studies. Different container closure system can be used.
Zejula 100 mg film-coated tablets
PRD9709363 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Substance synonyms
- NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XK02 — -
- Marketing authorisation
- EU/1/17/1235/004
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical image Niraparib Tablets, 100 mg used in clinical studies are identical to the commercial Zejula Tablets, 100 mg except the tablets are not debossed to maintain the blind in clinical studies. Different container closure system can be used.
PRD5625301 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Substance synonyms
- NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(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
- Yes
- Orphan designation number
- EU/3/10/760
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical image Niraparib Tablets, 100 mg used in clinical studies are identical to the commercial Zejula Tablets, 100 mg except the tablets are not debossed to maintain the blind in clinical studies. Different container closure system can be used.
Niraparib Tosilate Monohydrate
PRD8096048 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
Zejula 100 mg film-coated tablets
PRD9709386 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Substance synonyms
- NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XK02 — -
- Marketing authorisation
- EU/1/17/1235/005
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical image Niraparib Tablets, 100 mg used in clinical studies are identical to the commercial Zejula Tablets, 100 mg except the tablets are not debossed to maintain the blind in clinical studies. Different container closure system can be used.
PRD7910464 · Product
- Active substance
- Niraparib Tosilate Monohydrate
- Substance synonyms
- NIRAPARIB TOSYLATE MONOHYDRATE, MK-4827 TOSYLATE MONOHYDRATE, (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 324000 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XK02 — -
- Marketing authorisation
- EU/1/17/1235/002
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/760
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical image Niraparib Tablets, 100 mg used in clinical studies are identical to the commercial Zejula Tablets, 100 mg except the tablets are not debossed to maintain the blind in clinical studies. Different container closure system can be used.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Canter
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Canter
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management, E-data capture |
Locations
6 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 3 | 2 |
| France | Ended | 2 | 2 |
| Germany | Authorised, recruitment pending | 1 | 1 |
| Italy | Ongoing, recruiting | 1 | 1 |
| Romania | Authorised, recruitment pending | 1 | 1 |
| Spain | Ongoing, recruiting | 2 | 2 |
| Rest of world
Israel, United States, Canada
|
— | 17 | — |
Investigational sites
Medical University Of Graz
Gynaecology, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University of Vienna
Comprehensive Cancer Center, Medical University of Vienna, Waehringer Guertel 18-20, Alsergrund, Vienna
L'Hopital Prive Du Confluent
Service d’oncologie médicale, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Centre Antoine Lacassagne
Service d’oncologie médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Azienda Istituti Ospitalieri Di Cremona
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona, Viale Concordia 1, 26100, Cremona
Centrul De Oncologie SF Nectarie S.R.L.
Departamentul Oncologie Medicală, Strada Caracal Nr 109, 200542, Craiova
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 |
|---|---|---|---|---|---|
| Austria | 2021-11-25 | 2021-12-07 | |||
| France | 2021-10-13 | 2024-07-29 | 2021-10-18 | ||
| Italy | 2021-10-19 | 2021-10-26 | |||
| Spain | 2021-09-22 | 2021-10-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_COVID 19 Protocol Appendix 2023-506618-29-00_Redacted | 1 |
| Protocol (for publication) | D1_Protocol 2023-506618-29-00_Redacted | Am 1 |
| Protocol (for publication) | D1_Risk Benefit Assessment 2023-506618-29-00_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_RO_Redacted | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EN_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_RO_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_Redacted | 2.1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zejula | NA |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis_AUT_DEU_2023-506618-29-00_Redacted | Am 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ESP_2023-506618-29-00_Redacted | Am 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRA_2023-506618-29-00_Redacted | Am 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_ 2023-506618-29-00_Redacted | Am 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-15 | Spain | Acceptable 2023-09-26
|
2023-09-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-23 | Spain | Acceptable 2023-09-26
|
2025-01-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-22 | Spain | Acceptable 2023-09-26
|
2025-10-22 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-23 | 2026-02-02 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-11-26 | Acceptable 2023-09-26
|
2026-02-02 |