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This is an open-label, multi-center study to evaluate the safety of RAD001 in Chinese patients with metastatic renal cell cancer who are intolerant of or have progressed despite treatment with vascular endothelial growth factor (VEGF)-targeted therapies. All patients will be treated with RAD001 10 mg daily until tumor progression (determined according to the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death or discontinuation from the study for any other reason. At least 60 patients will be enrolled in the study. Screening and baseline evaluations will be performed within 28 days of the date when the patient signs the informed consent form. Baseline evaluations will be performed within two weeks of the first dose of RAD001. Screening and baseline evaluations will be performed to determine if patient meets all inclusion and exclusion criteria. All eligible patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days. After discontinuation of treatment with RAD001, patients will have a safety follow-up performed 28 days after the last dose of RAD001. Patients must continue with survival assessments which will be performed every 3 months from the last dose of RAD001 until up to 2 years after the last patient's first visit date.
An interim analysis focusing on safety data and a final analysis of all data are planned. All patients still receiving the study drug at the time of the final analysis will be given the option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or disease progression.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
Novartis Investigative Site
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:08:39-0400
Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients. T...
Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.
This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.
This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination ...
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma f...
The mammalian target of rapamycin (mTOR) pathway is a critical target for cancer treatment and the mTOR inhibitor everolimus (RAD001) has been approved for treatment of renal cell carcinoma (RCC). How...
The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment wi...
Renal cell carcinoma is the 14th most common cancer worldwide. It is a heterogeneous group of histopathological entities, of which the most common is clear cell renal cell carcinoma. Approximately 20-...
The expression of IL-8 and FGFR has been related to prognosis and pathological features in renal cell carcinoma. We investigated the relationship between IL-8 and FGFR and the outcome in metastatic re...
Cabozantinib prolongs overall survival (OS) and progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (RCC) that progressed on first-line vascular endothelial gro...
A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.
An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A rare tumor of the female genital tract, most often the ovary, formerly considered to be derived from mesonephric rests. Two varieties are recognized: (1) clear cell carcinoma, so called because of its histologic resemblance to renal cell carcinoma, and now considered to be of muellerian duct derivation and (2) an embryonal tumor (called also ENDODERMAL SINUS TUMOR and yolk sac tumor), occurring chiefly in children. The latter variety may also arise in the testis. (Dorland, 27th ed)
A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.
Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type. In renal cell cancer the cancerous cells start in the lini...