- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00478114
Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma (RCC)
An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Renal cell carcinoma (RCC) accounts for approximately 3 % of all cancers. RCC can be cured if diagnosed and treated when still localized to the kidney or immediate surrounding tissues. Since most of the RCC tumours are diagnosed when still localized, approximately 40 % of all patients survive 5 years. The median survival of Stage IV RCC after diagnosis is 8 to 12 months and the 5-year survival is less than 10 %. Surgery has been the primary therapy for RCC for more than a century. Until recently, metastatic disease has been refractory to any systemic therapy. Despite recent advances in immunotherapy (e.g. Interferon and Interleukin-2), the response rates remain low (15 %) and few patients experience durable remission. Surgical and radiation therapies for Stage IV disease are generally limited to palliation of symptoms. For the majority of patients, metastatic RCC is incurable and patients should be considered candidates for clinical trials when appropriate. In summary, the available therapies for advanced unresectable and/or metastatic RCC have limited clinical values, with response rates ranging from 6-20 % and little impact on the natural history of the disease. Furthermore, the toxicities associated with these agents can be severe, requiring careful patient selection, and this dramatically decreases the number of patients who may benefit from therapy. Advanced RCC remains incurable and the need for more effective therapies is high.
This is a non-randomized, open-label treatment protocol for patients with advanced RCC. Patients will be treated with 400 mg oral sorafenib twice a day on a continuous. Patients in this protocol may continue to be treated with sorafenib as a single agent until any of the following criteria for drug or protocol discontinuation is reached:
- Progression of disease.
- The patient is unlikely to benefit from further treatment with sorafenib as judged by the Investigator.
- Intolerable toxicity of the drug.
- Withdrawal of consent for any reason.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Bangkok
-
Bangkoknoi, Bangkok, Tailandia, 10700
- Siriraj Hospital, Department of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Written informed consent prior to receiving sorafenib.
- At least 18 years of age.
- Advanced Renal Cell Carcinoma.
- A patient who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i.e. resolved back to CTC-AE Grade 1 or less).
- For patients, who have had major surgery or injury, the wound must be completely healed prior to receiving sorafenib treatment (4 weeks).
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men must use adequate birth control for at least 3 months after the last administration of sorafenib. Should a woman become pregnant while participating or while the partner of a patient is participating in the study, they should inform their treating physician immediately.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Patients with metastatic brain or meningeal tumours.
- Cardiac disease: greater than NYHA functional class II; unstable CAD; MI within the last 6 months.
- HIV infection or chronic hepatitis B or C; patients with Child-Pugh class C hepatic impairment.
- Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
- Patients with active uncontrolled hypertension.
- Patients with recent or active bleeding diathesis.
- Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
Excluded therapies or medications, previous and concomitant:
- Bone marrow transplant or stem cell rescue within 4 months of study entry.
- Anticipation of the need for major surgery during the course of the study.
- CYP 3A4 inducers (e.g. rifampicin, St. John's Wort [Hypericum perforatum], phenytoin, phenobarbital and dexamethasone).
Any investigational therapy while on this protocol or within 30 days prior to their first dose of sorafenib.
- Any drugs (licensed or investigational) that targets angiogenesis, especially VEGF or VEGF-Receptors (e.g. bevacizumab).
- Any drug (licensed or investigational) that targets Ras-pathway or EGFR.
- Biological response modifiers, such as G-CSF or GM-CSF, within 3 weeks prior to study entry or during study (G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity such as febrile neutropenia, when medically indicated or at the discretion of the Investigator).
- Use of Megestrol-acetate and medroxyprogesterone.
- Patients taking narrow therapeutic index medications will be monitored closely.
- These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine and digoxin.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
Sorafenib
|
sorafenib in the patients with advanced Renal Cell Carcinoma
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC
Periodo de tiempo: two years
|
two years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To evaluate the safety (all drug-related adverse events, all adverse events NCI CTCAE 3.0 Grade 3 or higher) of sorafenib in patients with advanced RCC
Periodo de tiempo: two years
|
two years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vichien Srimuninnimit, Ass.Prof., Siriraj Hospital, Bangkok, Thailand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Carcinoma
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Sorafenib
Otros números de identificación del estudio
- 12750
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. .
Ensayos clínicos sobre Carcinoma de células renales
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and Kidney... y otros colaboradoresReclutamientoEnfermedades Renales Crónicas | Fallo renal agudo | Lesión renal aguda | Insuficiencia Renal Aguda | Insuficiencia renal cronica | Insuficiencia Renal, Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia renal aguda | Insuficiencia Renal Crónica | Enfermedades... y otras condicionesEstados Unidos
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillTerminadoEnfermedades Renales Crónicas | Enfermedad Renal Crónica Etapa 5 | Enfermedad Renal Crónica etapa 4 | Enfermedad renal pediátrica | Enfermedad Renal Crónica etapa 3 | Enfermedad Renal Crónica Etapa V | Enfermedad renal crónica, estadio IV (grave) | Enfermedad Renal Crónica Etapa 2 | Enfermedad Renal...Estados Unidos
-
University Hospital, BordeauxMinistry of Health, FranceTerminadoTrasplante Renal | Enfermedad renal crónica en etapa terminal | Insuficiencia Renal Aguda SeveraFrancia
-
Wake Forest University Health SciencesStanford UniversityTerminadoTrasplante Renal | Rechazo Renal Agudo | Rechazo Renal Crónico | Rechazo de Trasplante Renal | Sistema Renina-AngiotensinaEstados Unidos
-
Faculdade de Ciências Médicas da Santa Casa de...TerminadoEnfermedad Renal Crónica | Diálisis renalBrasil
-
Outset MedicalTerminadoLesión renal aguda | Enfermedad renal en etapa terminal (ESRD) | Enfermedad renal en etapa terminal en diálisisEstados Unidos
-
Novartis PharmaceuticalsTerminadoHemodiálisis | Terapia de reemplazo renal | Enfermedad renal en etapa terminal (ESRD) | Trasplante Renal | Enfermedad renal crónica (ERC)Alemania, Estados Unidos, Bélgica, Italia, España, Croacia, Taiwán, Australia, Austria, Grecia, Corea, república de, Líbano, Chequia, Israel, Países Bajos, Eslovenia, Suiza, Tailandia, Noruega, Pavo, Suecia, Argentina, Brasil, Japón, Serbia, Federación Rusa y más
-
ArdelyxAstraZenecaTerminadoEnfermedad renal en etapa terminal | ESRD | Enfermedad Renal Crónica Etapa 5Estados Unidos
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)TerminadoFallo renal agudo | Insuficiencia renal cronicaAustria
-
Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos
Ensayos clínicos sobre sorafenib
-
BayerAmgenTerminado
-
Technical University of MunichTerminadoCarcinoma de células renalesAustria, Alemania, Países Bajos
-
Ottawa Hospital Research InstituteBayerTerminadoCáncer colorrectal metastásicoCanadá
-
Yiviva Inc.ReclutamientoCarcinoma hepatocelular avanzadoEstados Unidos, Taiwán, Porcelana, Hong Kong
-
British Columbia Cancer AgencyRetiradoCarcinomas de células escamosas de cabeza y cuello localmente avanzados (SCCHN)Canadá
-
Ohio State University Comprehensive Cancer CenterBayerTerminado
-
Cancer Institute and Hospital, Chinese Academy...TerminadoCarcinoma Hepatocelular, Radioterapia, SorafenibPorcelana
-
BayerTerminadoCarcinoma hepatocelularTaiwán
-
New Mexico Cancer Care AllianceTerminadoCarcinoma metastásico de células renalesEstados Unidos
-
Xspray Pharma ABTerminadoFarmacocinética | BiodisponibilidadReino Unido