A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma
- Participants will be given a supply of the study drug RAD001 to be taken at home. They
will be asked to take the study drug every morning on an empty stomach and will be
given a study drug diary to record the time/date each time they take RAD001. Each 6
week period of time is called a cycle of study treatment.
- We are looking for the highest dose of RAD001 that can be given safely. Therefore not
every participant will receive the same dose of RAD001.
- Participants will come to the clinic every other week. At each of these visits, a
physical examination and blood tests will be performed.
- A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then
every 12 weeks thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of RAD001 in patients with advanced hepatocellular carcinoma (HCC).
Andrew X. Zhu, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|