Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
10 de enero de 2019 actualizado por: Ipsen
A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
6
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 4L6
- London Health Sciences Centre, University of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Department of Oncology, Ottawa Cancer Center
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Toronto, Ontario, Canadá, M5G 2M9
- Dept of Obstetrics and Gynecology, Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canadá, H2L 4M1
- CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
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Montreal, Quebec, Canadá, H2W 1S6
- Department of Oncology, McGill University
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Georgia
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Augusta, Georgia, Estados Unidos, 30912
- Dept of Obstetrics and Gynecology, Medical College of Georgia
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Division of Gynecologic Oncology, University of Minnesota Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
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Upland, Pennsylvania, Estados Unidos, 19103
- Crozer Chester Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Exclusion Criteria:
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: BN83495
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1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
Periodo de tiempo: 12 weeks
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CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Adverse Events
Periodo de tiempo: Up to 28 days after last dose
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Up to 28 days after last dose
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Determination of Time to Progression (TTP) in This Patient Population
Periodo de tiempo: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Progression Free Survival (PFS) in This Patient Population
Periodo de tiempo: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Response Rate (ORR) in This Patient Population
Periodo de tiempo: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Overall Response Rate (ORR): Defined as the sum of CR and PR.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Duration of Response in This Patient Population
Periodo de tiempo: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Survival in This Patient Population
Periodo de tiempo: 2 years after the last patient enrolled
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Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
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2 years after the last patient enrolled
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de junio de 2011
Finalización del estudio (Actual)
1 de julio de 2011
Fechas de registro del estudio
Enviado por primera vez
23 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
30 de noviembre de 2010
Publicado por primera vez (Estimar)
1 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
10 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- X-52-58064-007
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. .