Status:
COMPLETED
Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 vascula...
Eligibility Criteria
Inclusion
- Patients of Chinese origin who are ≥ 18 years old.
- Patients with histologically or cytologically confirmed metastatic renal cell carcinoma.
- Patients who are intolerant of or who have progression on or after stopping treatment with VEGF-targeted therapies within 6 months. Note: Prior treatment with vaccine therapy in the adjuvant setting and prior treatment with cytokines (i.e., IL-2, Interferon) or chemotherapy is permitted.
- Patients with at least 1 measurable lesion determined according to the RECIST Criteria Guidelines.
- Patients with history of brain metastasis who are clinically judged by the investigator as neurologically stable following definitive radiation or surgery and do not require corticosteroids may be enrolled in the study.
- 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 which is defined as serum creatinine ≤ 2 x ULN.
- Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of RAD001.
- Patients must give written informed consent according to local guidelines
Exclusion
- Patients who have received chemotherapy, immunotherapy, radio-therapy or any other investigational agent (including pazopanib, axitinib) within 4 weeks of study entry, or have received sunitinib® and/or sorafenib® within 2 weeks 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 who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
- Patients receiving chronic and 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 a clinically significant active bleeding diathesis.
- Patients with known HIV seropositivity, hepatitis B or C seropositivity. Patients with prior hepatitis B vaccination may be entered in the study after review of hepatitis test results by the investigator.
- 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 hypercholesterolemia (\>300 mg/dL or 7.75 mmol/L),uncontrolled diabetes (fasting glucose \> 2x ULN),an active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis.
- 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, and up to 8 weeks after ending treatment. Hormonal contraceptives are not acceptable as a sole method of contraception
- Other protocol related inclusion/exclusion criteria
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01152801
Start Date
May 1 2010
End Date
December 1 2013
Last Update
December 21 2020
Active Locations (7)
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1
Novartis Investigative Site
Wuhan, Hubei, China, 430030
2
Novartis Investigative Site
Nanjing, Jiangsu, China, 210002
3
Novartis Investigative Site
Beijing, China, 100028
4
Novartis Investigative Site
Beijing, China, 100036