- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07747506
Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Open-Label Extension Study to Provide Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Verastem Call Center
- Número de teléfono: 781-292-4204
- Correo electrónico: clinicaltrials@verastem.com
Ubicaciones de estudio
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Lyon, Francia, 69008
- Centre Léon Bérard
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Investigador principal:
- Isabelle Ray-Coquard, MD
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Contacto:
- Isabelle Ray-Coquard, MD
- Número de teléfono: +33 478782888/5912
- Correo electrónico: isabelle.ray-coquard@lyon.unicancer.fr
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Paris, Francia, 75248
- Institut Curie
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Investigador principal:
- Manuel Rodrigues, MD
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Contacto:
- Manuel Rodrigues, MD
- Correo electrónico: manuel.rodrigues@curie.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Currently active on VS-6766-201(RAMP-201) study while receiving avutometinib in combination with defactinib, have not required prior permanent discontinuation of avutometinib plus defactinib. Any active dose hold from the RAMP-201 study should be ≤ 28 days at the time of Screening for the OLE study.
- Investigator assessment that the participant is deriving clinical benefit from study treatment (e.g., complete response, partial response, or stable disease), as determined by the investigator.
Female participants of childbearing potential must agree to use a highly effective method of contraception throughout OLE study participation and for at least 30 days after the last dose of study treatment.
Note: Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening/Eligibility prior to the first OLE dose.
- Ability and willingness to provide written informed consent for participation in the study and for continued data collection.
Exclusion Criteria:
- Radiographic or clinical disease progression or discontinuation of treatment for any reason during the VS-6766-201 (RAMP-201) study or at the time of screening in this study.
- Participants on an active dose hold in the VS-6766-201 (RAMP-201) study may transition to this study only after the underlying issue has been clinically resolved and the investigator, in consultation with the Sponsor, confirms that continued treatment is appropriate.
- Receipt of new systemic anti-cancer therapy since participation in the RAMP-201 study.
- Participation in another interventional clinical study or receipt of other investigational therapy since participation in VS-6766-201 (RAMP-201) study.
- Any active or uncontrolled medical condition that, in the investigator's judgment, would pose unacceptable risk or interfere with continued treatment, including but not limited to severe cardiac, pulmonary, neurologic, dermatologic, gastrointestinal, hepatic, or active infectious disease.
- Any active or history of clinically significant ocular disorder that may increase the risk of MEK-inhibitor-related ocular toxicity (e.g., retinal vein occlusion, serous retinopathy, retinal detachment, or clinically significant macular pathology).
- Concomitant use of medications known to have clinically significant interactions with avutometinib or defactinib that cannot be safely discontinued or substituted prior to study dosing (e.g., strong CYP3A4 inducers or inhibitors, warfarin).
- Positive pregnancy test at Screening, breastfeeding, or unwillingness to use adequate contraception during the study.
- Any condition or circumstance that, in the investigator's opinion, may compromise participant safety, compliance or continued benefit from study treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Continued Treatment of Avutometinib + Defactinib
To provide continued treatment with avutometinib in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the VS-6766-201 (RAMP-201) study
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Avutometinib: administered orally twice a week Defactinib: administered orally twice daily
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Periodo de tiempo: Until treatment discontinuation (approximately 20 months)
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Treatment exposure will be summarized descriptively for participants receiving continued treatment with avutometinib in combination with defactinib after completion of Study VS-6766-201 (RAMP-201).
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Until treatment discontinuation (approximately 20 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Periodo de tiempo: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
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Treatment-emergent adverse events will be collected and summarized for participants receiving extended treatment with avutometinib alone or in combination with defactinib.
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From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: MD Verastem, Verastem Oncology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Neoplasias Ováricas
- desglose
Otros números de identificación del estudio
- VS-6766-206
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .