Cholangiocarcinoma Clinical Trial
Official title:
Phase II Study of RAD001 in Advanced Cholangiocarcinoma
This is a clinical trial investigating the effectiveness and safety of the study drug RAD001
in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides
some benefit to this group of patients. However, chemotherapy treatment only shows low rates
of radiological response and short times to tumour progression. Therefore, further treatment
options are urgently required.
In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use
to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the
treatment of kidney cancer. It has also been approved for use in Australia for the treatment
of patients with kidney and liver transplants, and has been used in thousands of patients
worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in
a range of other cancers. This study will evaluate the activity 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
progression.
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
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