An Extension Study to Evaluate Subjects Who Have Benefited from Previous Treatment with Niraparib

Overview

Información sobre este estudio

The purpose of this study is to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Gerardo Colon-Otero, M.D.

Cerrado para la inscripción

Contact information:

Gerardo Colon-Otero M.D.

(904) 953-2693

gcolonotero@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20520637

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