Resumen

El propósito de este estudio es evaluar la seguridad a largo plazo de ribociclib (LEE011) en combinación con otros fármacos y proporcionar acceso post-ensayo (APE) a los participantes que actualmente reciben tratamiento con ribociclib en combinación con otros fármacos y siguen obteniendo beneficio clínico en un estudio global patrocinado por Novartis que ha alcanzado su(s) objetivo(s) primario(s).

Descripción detallada

Se trata de un estudio de extensión abierto y multicéntrico para evaluar la seguridad a largo plazo de ribociclib en combinación con otros fármacos en participantes que están participando en un estudio global patrocinado por Novartis, que ha cumplido los requisitos para su(s) objetivo(s) primario(s), y que, a juicio del investigador, se beneficiarían de continuar el tratamiento. Este estudio de extensión no incluirá una fase de tamizaje; los participantes pasarán directamente al completar el estudio parental. Los participantes elegibles comenzarán a recibir ribociclib en combinación con otros fármacos (según el protocolo parental) únicamente después de haber firmado el Consentimiento Informado y de haber cumplido los criterios de selección para este estudio de extensión. Los participantes deben acudir al centro del estudio para reabastecimiento del medicamento del estudio y para la evaluación de seguridad y beneficio clínico, como mínimo cada 24 semanas, o con mayor frecuencia en cualquier momento requerido según la práctica local.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Signed informed consent must be obtained prior to participation in the study.
Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s).
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
Participant must have evidence of clinical benefit as determined by the Investigator.

Criterios de exclusión

Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:
Total abstinence
Female sterilization
Male partner sterilization
Placement of an intrauterine device (IUD)
Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations.

Intervenciones

drug

Ribociclib

Participants continue ribociclib as was administered in their parent study

drug

Letrozole

Participants continue ribociclib in combination with letrozole as was administered in their parent study

drug

Anastrozole

Participants continue ribociclib in combination with anastrozole as was administered in their parent study

drug

Goserelin

Participants continue ribociclib in combination with goserelin as was administered in their parent study

drug

Tamoxifen

Participants continue ribociclib in combination with tamoxifen as was administered in their parent study

drug

Fulvestrant

All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Estudio de extensión post-ensayo para permitir el acceso a ribociclib (LEE011) en pacientes que se encuentran en tratamiento con ribociclib en un estudio patrocinado por Novartis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Ribociclib

Letrozole

Anastrozole

Goserelin

Tamoxifen

Fulvestrant

Ubicaciones

Novartis Investigative Site

Patrocinadores