Pacientes con carcinoma renal metastásico que han progresado a pesar de la terapia con inhibidor de tirosina quinasas del receptor del factor de crecimiento endotelial vascular MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Sponsors
Novartis Farmacéutica, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years old. • Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable). • Patients must have progression on or after stopping treatment with any component of VEGF receptor tyrosine kinase inhibitor therapy (sunitinib and/or sorafenib). • Prior vaccine therapy or treatment with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors (i.e., bevacizumab) is permitted. • Patients with measurable or non-measurable disease by RECIST criteria. • Patients with history of another distinguishable malignancy (such as non-melanoma skin cancer, or low grade lymphoma, or CLL, or well controlled low grade prostate cancer), which are neither life threatening nor require chemotherapy or radiation. • Patients with history of brain metastasis who are neurologically stable following definitive radiation or surgery and do not require corticosteroids. • Patients with a Karnofsky Performance Status =70%. • Patients with adequate bone marrow function defined as ANC = 1.5 x 109/L, Platelets = 100 x 109/L, Hgb >9 g/dL. • Patients with adequate liver function defined as serum bilirubin = 1.5 x ULN, ALT and AST = 2.5x ULN. Patients with known liver metastases who have an AST and ALT = 5x ULN. • Patients with adequate renal function defined as serum creatinine = 2 x ULN. • Women of childbearing potential must have had a negative serum or urine pregnancy test within 14 days prior to the administration of study drug. • Patients must give written informed consent according to local guidelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients receiving chemotherapy, immunotherapy, radio-therapy or any other investigational agent within 4 weeks of study entry, or sunitinib and/or sorafenib within 1 week of the first dose of RAD001. • Patients who have previously received RAD001 or other mTOR inhibitors. • Patients with a known hypersensitivity to RAD001 or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients. • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone = 20 mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose = 4 weeks prior to the first dose of RAD001. Topical or inhaled corticosteroids are permitted. • Patients with an active bleeding diathesis. • Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function. • Uncontrolled diabetes (fasting glucose > 2x ULN) • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, they must be continued throughout the study by both sexes. • Patients unwilling to or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To provide expanded access to RAD001 in patients with MRCC whose disease has progressed despite prior VEGF receptor tyrosine kinase inhibitor therapy, until the product is commercially available for MRCC in each participating country. - To evaluate the safety profile of RAD001 in patients with MRCC whose disease has progressed despite prior VEGF receptor tyrosine kinase inhibitor therapy ;Secondary Objective: - To evaluate the investigator’s best overall response rate of RAD001 in patients with MRCC whose disease has progressed despite prior VEGF receptor tyrosine kinase inhibitor therapy, until the product is commercially available for MRCC in each participating country.;Primary end point(s): Safety: • Grade 3 and 4 Adverse Events, Serious Adverse Events | — |
Countries
Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed