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The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer. Phase II part of the study will determine safety, response rate,progression free survival and time to disease progression in kidney cancer patients.
Phase I of the study will be an open-label dose escalation study to determine the MTD of the combination of sorafenib and RAD001. There will be a 7-day sorafenib run-in period prior to starting of RAD001 during cycle 1 to determine the pharmacokinetic effect of adding RAD001 on sorafenib drug levels. Starting doses will be set at RAD001 2.5 mg PO QD and sorafenib 400mg PO BID, continuously. Cycle length will be 4 weeks. Between 3 and 18 patients will be treated in the phase I portion of this study.
In Phase II, 49 patients will be treated at the RP2D of the combination of RAD001 and sorafenib (including the 6 patients treated at the MTD on the phase I portion of this study). Patients will take the RP2 doses of sorafenib PO BID and RAD001 PO QD. Drug dosing will continue until disease progression or unacceptable toxicity.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Renal Cell Carcinoma
RAD001 and Sorafenib
University of California, San Francisco
Active, not recruiting
University of California, San Francisco
Published on BioPortfolio: 2014-08-27T03:42:12-0400
The purpose of this study is to see whether the combination for RAD001 and Nexavar® works better when given together than they do alone. The purpose of the first phase of this study is to...
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma
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.
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
To fully clarify the role of Mitogen Activated Protein Kinase in the therapeutic response to Sorafenib in Renal Cell Carcinoma as well as the cell death mechanism associated to this kinase inhibitor, ...
The purpose of this work was to investigate the effect of sorafenib or sunitinib as neoadjuvant therapy on the survival outcomes of renal cell carcinoma (RCC) with tumor thrombus.
Advanced cancer has been shown to be associated with a higher percentage of epigenetic changes than with genetic mutations. Preclinical models have shown that the combination of paclitaxel, sorafenib,...
Metastasis-directed therapy of small solitary foci of metastatic renal cell carcinoma has been associated with improved survival. Percutaneous resection of tumors in the upper tract urinary system has...
Clear cell renal cell carcinoma (CCRCC) is the most aggressive form of renal cell carcinoma (RCC).
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 carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...
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