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
- metastatic kidney cancer / metastatic renal cell carcinoma10038364
- Registration Number
- NL-OMON33782
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
• 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 nonmelanoma 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.
• 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 (e.g., intra-thoracic, intra-abdominal, or intra-pelvic),
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Grade 3/4 adverse events and serious adverse events will be captured</p><br>
- Secondary Outcome Measures
Name Time Method <p>Tumor response and progression will be assessed using RECIST Criteria.Tumor<br /><br>assessments of measurable (CT scan/MRI) disease/lesions will be performed at<br /><br>screening and repeated every 3 months for the first year and then every 6<br /><br>months thereafter, and at discontinuation of the study drug. Lesion size and<br /><br>measurements will not be collected; however, the Investigator*s best overall<br /><br>response will be captured.<br /><br><br /><br>After the administration of the last dose of RAD001 or RAD001 becomes<br /><br>commercially available, no further AEs/SAEs or survival data will be collected<br /><br>after the required 28 day safety interval.</p><br>