An open-label, multi-center, expanded access study of RAD001 in patients with metastatic carcinoma of the kidney who are intolerant of or have progressed despite any available vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy
- Conditions
- Patients with metastatic carcinoma of the kidney who are intolerant of or have progressed despite any available vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor therapy.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinoma
- Registration Number
- EUCTR2007-005460-28-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
• Age = 18 years old.
•Patients with histologically or cytologically confirmed metastatic renal cell carcinoma.
• Patients who are intolerant of or have progression on or after stopping treatment with any available VEGF receptor tyrosine kinase inhibitor therapy
• 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
• Patients receiving chemotherapy, immunotherapy, radio-therapy or any other investigational agent (including pazopanib) 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 systemic treatment with corticosteroids or another immunosuppressive agent. Patients may receive low dose treatment of corticosteroids with a maximum dose of 20 mg prednisone or 10 mg dexamethasone per day, if they are being given for disorders such as rheumatoid arthritis, asthma, or adrenal insufficiency. Topical or inhaled corticosteroids are permitted.
• Patients with an active bleeding diathesis.
• Patients who have undergone major surgery within 4 weeks prior to starting study drug, open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -- To evaluate the safety profile of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinase inhibitor therapy<br>;Secondary Objective: - To evaluate the investigator’s best overall response rate of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinase inhibitor therapy.<br>- To provide expanded access to RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinase inhibitor therapy, until the product is commercially available (nat applicable in zhe UK and Norway)for MRCC in each participating country or until 15 Jun 2010.<br>;Primary end point(s): Safety:<br>• Grade 3 and 4 Adverse Events, Serious Adverse Events<br>
- Secondary Outcome Measures
Name Time Method