- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01512186
A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther) (Panther)
A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design
Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.
After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Basildon, Reino Unido
- Basildon and Thurrock University Hospitals NHS Foundation Trust
-
Coventry, Reino Unido
- University Hospitals Coventry & Warwickshire NHS Trust
-
Glasgow, Reino Unido
- The Beatson West of Scotland Cancer Centre
-
London, Reino Unido
- Barts and London Hospital NHS Trust
-
London, Reino Unido
- Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
-
London, Reino Unido
- Oncology & Haematology Clinical Trials Unit, Guy's Hospital
-
Oxford, Reino Unido
- Department of Oncology Oxford Cancer Centre
-
Southampton, Reino Unido
- Southampton General Hospital
-
Southend, Reino Unido
- Southend University Hospital Trust
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.
- No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.
Adequate organ function as defined by the following criteria:
i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- ECOG performance status of 0, 1 or 2.
- 18 years or above (no upper age limit) Male or female
Exclusion Criteria:
Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.
- Previous treatment for renal cancer
- Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
- Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs
- Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
- Bleeding diathesis
- Current uncontrolled hypertension
- Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
Periodo de tiempo: Interim analysis after 34 patients have 12 weeks of treatment
|
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
|
Interim analysis after 34 patients have 12 weeks of treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Surgical complications (blood loss, post operative complications, hospital stay)
Periodo de tiempo: After the first 20 patients have had a nephrectomy
|
Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.
|
After the first 20 patients have had a nephrectomy
|
Overall Survival
Periodo de tiempo: After three years of study
|
Overall survival will be measured from start of treatment to time of death.
|
After three years of study
|
Progression free survival
Periodo de tiempo: After all patients have progresssed
|
Progression free survival will be measured from start of study treatment to time of disease progression.
|
After all patients have progresssed
|
Local response of primary tumour to pazopanib
Periodo de tiempo: After 12 weeks of study drug
|
After 12 weeks of study drug
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 2009-016675-29
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 Cáncer renal metastásico de células claras
-
Ludwig Institute for Cancer ResearchMemorial Sloan Kettering Cancer CenterTerminadoCancer de RIÑON | Carcinoma de células renales | Cáncer renal | Neoplasia RenalEstados Unidos
-
National Cancer Institute (NCI)Terminado
-
National Cancer Institute (NCI)TerminadoCancer de RIÑON | Cáncer renalEstados Unidos
-
Aesculap AGTerminadoCancer de RIÑON | Nefrolitiasis | Cancer de prostata | Nefritis | Lesión renal | Hidronefrosis | Anomalía congénita del riñón | Tuberculosis renalAlemania
-
Five Eleven Pharma, Inc.Activo, no reclutandoCancer de prostata | Cáncer renalEstados Unidos
-
SCRI Development Innovations, LLCGenentech, Inc.TerminadoCancer de RIÑON | Cáncer renalEstados Unidos
-
Institut du Cancer de Montpellier - Val d'AurelleLigue contre le cancer, FranceReclutamiento
-
SCRI Development Innovations, LLCNovartis; Genentech, Inc.TerminadoCancer de RIÑONEstados Unidos
-
Bristol-Myers SquibbOno Pharma USA IncTerminadoCancer de RIÑON | Cáncer renalJapón
-
Memorial Sloan Kettering Cancer CenterTerminadoCancer de RIÑON | Cáncer renalEstados Unidos