Phase II Study of RAD001 in Advanced Cholangiocarcinoma
27 patients from approximately four hospitals in Australia will participate in this trial,
with approximately 15 patients being enrolled at Austin Health. All participants will
receive the same treatment (RAD001 10mg/d given orally).
After screening for eligibility, participants will receive RAD001 10mg/d until tumour
Participants will undergo regular CT scans (every 6 weeks during treatment) to evaluate the
effectiveness of treatment. Providing they are tolerating treatment satisfactorily, they may
receive study treatment until progression of disease.
Blood samples will be taken during the screening phase and every 3 weeks during the
treatment phase of the trial. Participants will be followed-up every 3 months to find out
about survival status, new chemotherapy or biological treatment and the outcome of any
ongoing adverse events.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Australia: Human Research Ethics Committee