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GlaxoSmithKlineA Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study Fase II 30
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT04641247 è uno studio interventistico di Fase II volto a esaminare il trattamento per Neoplasie Ovariche, Neoplasie al seno, attualmente in arruolamento. Avviato il 16 aprile 2021, prevede di arruolare 30 partecipanti. Sotto la guida di GlaxoSmithKline, dovrebbe concludersi entro il 13 novembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 settembre 2025.
Sommario breve
This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.
Titolo ufficiale
An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib
Patologie
Neoplasie OvaricheNeoplasie al senoAltri ID dello studio
- 213409
- 2020-002667-53 (Numero EudraCT)
- 2023-506618-29 (Identificativo del registro) (CTIS)
Numero NCT
Data di inizio (effettiva)
2021-04-16
Ultimo aggiornamento pubblicato
2025-09-29
Data di completamento (stimata)
2026-11-13
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
Adverse events
Open-label extension
Parent study
Niraparib
Safety
Open-label extension
Parent study
Niraparib
Safety
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleParticipants receiving niraparib Participants will receive niraparib once a day, continuously throughout each 90-day cycle until one of the following occurs: disease progression, unacceptable toxicity, initiation of new anticancer therapy that was not part of the parent study, withdrawal of consent, discontinuation at the discretion of the Investigator, noncompliance with protocol, death, or discontinuation for any other reason. The doses provided i...Mostra di più | Niraparib Niraparib tablets or capsules will be given once a day via the oral route. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) | AEs, SAEs and AESI will be collected. | Up to 5 years |
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status | The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized. | Up to 5 years |
Number of participants with clinically significant changes in hematology and clinical chemistry parameters | Blood samples will be collected for the analysis of hematology and clinical chemistry parameters. | Up to 5 years |
Number of participants with clinically significant changes in vital signs | Number of participants with clinically significant changes in vital signs will be assessed. | Up to 5 years |
Number of participants with clinically significant changes in physical examination | Number of participants with clinically significant changes in physical examination will be assessed. | Up to 5 years |
Number of participants with use of concomitant medications | Number of participants using concomitant medications will be assessed. | Up to 5 years |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
- Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.
- Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective.
- Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.
- Participants 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.
- Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.
- Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.
- Participant 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. Participant 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).
GlaxoSmithKline254 studi clinici attivi da esplorareContatti principali dello studio
Contatto: US GSK Clinical Trials Call Center, 877-379-3718, [email protected]
Contatto: EU GSK Clinical Trials Call Center, +44 (0) 20 89904466, [email protected]
25 Centri dello studio in 8 paesi
GSK Investigational Site, Cremona, 26100, Italy
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Daniele Generali, Investigatore principale
In arruolamento
Arizona
GSK Investigational Site, Tucson, Arizona, 85710, United States
Completato
California
GSK Investigational Site, Encinitas, California, 92024, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Alberto Bessudo, Investigatore principale
In arruolamento
GSK Investigational Site, Los Angeles, California, 90048, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Bobbie Rimel, Investigatore principale
In arruolamento
GSK Investigational Site, Whittier, California, 90603, United States
Completato
Florida
GSK Investigational Site, Jacksonville, Florida, 32224, United States
Completato
Georgia
GSK Investigational Site, Atlanta, Georgia, 30342, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Meaghan Tenney, Investigatore principale
In arruolamento
Illinois
GSK Investigational Site, Harvey, Illinois, 60426, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Ivy Abraham, Investigatore principale
In arruolamento
Massachusetts
GSK Investigational Site, Boston, Massachusetts, 02115, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Wendy Y Chen, Investigatore principale
In arruolamento
Michigan
GSK Investigational Site, Grand Rapids, Michigan, 60637-1470, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Manish Sharma, Investigatore principale
In arruolamento
New Jersey
GSK Investigational Site, Morristown, New Jersey, 07962-1956, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Nana Eleonore Tchabo, Investigatore principale
In arruolamento
New York
GSK Investigational Site, Lake Success, New York, 11042, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Veena John, Investigatore principale
In arruolamento
North Carolina
GSK Investigational Site, Charlotte, North Carolina, 28204, United States
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Antoinette Tan, Investigatore principale
In arruolamento
Ohio
GSK Investigational Site, Cleveland, Ohio, 44195, United States
Completato
GSK Investigational Site, Graz, A-8036, Austria
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Edgar Petru, Investigatore principale
In arruolamento
GSK Investigational Site, Vienna, 1090, Austria
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Stephan Polterauer, Investigatore principale
In arruolamento
British Columbia
GSK Investigational Site, Kelowna, British Columbia, V5Z 4E6, Canada
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Anna Tinker, Investigatore principale
In arruolamento
Ontario
GSK Investigational Site, Toronto, Ontario, M5G 2M9, Canada
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Amit M. Oza, Investigatore principale
In arruolamento
Quebec
GSK Investigational Site, Montreal, Quebec, H4A 3J1, Canada
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Lucy Gilbert, Investigatore principale
In arruolamento
GSK Investigational Site, Odense C, 5000, Denmark
Completato
GSK Investigational Site, Nantes, 44202, France
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Alain Lortholary, Investigatore principale
In arruolamento
GSK Investigational Site, Nice, 06189, France
Completato
GSK Investigational Site, Haifa, 3109601, Israel
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Emad Matanes, Investigatore principale
In arruolamento
GSK Investigational Site, Madrid, 28040, Spain
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Antonio Casado Herráez, Investigatore principale
In arruolamento
GSK Investigational Site, Madrid, 28046, Spain
US GSK Clinical Trials Call Center, Contatto, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, Contatto, +44 (0) 20 8990 4466, [email protected]
Andrés Redondo Sánchez, Investigatore principale
In arruolamento