Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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 vascular endothelial growth factor (VEGF)-targeted therapies. All patients
will be treated with RAD001 10 mg daily until tumor progression (determined according to the
Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death
or discontinuation from the study for any other reason. At least 60 patients will be enrolled
in the study. Screening and baseline evaluations will be performed within 28 days of the date
when the patient signs the informed consent form. Baseline evaluations will be performed
within two weeks of the first dose of RAD001. Screening and baseline evaluations will be
performed to determine if patient meets all inclusion and exclusion criteria. All eligible
patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg
daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every
month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days.
After discontinuation of treatment with RAD001, patients will have a safety follow-up
performed 28 days after the last dose of RAD001. Patients must continue with survival
assessments which will be performed every 3 months from the last dose of RAD001 until up to 2
years after the last patient's first visit date.
An interim analysis focusing on safety data and a final analysis of all data are planned. All
patients still receiving the study drug at the time of the final analysis will be given the
option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or
disease progression.