Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol (RADiChol)

Inclusion Criteria:

1. Histologically/cytologically confirmed adenocarcinoma of gall bladder, intra or extra-hepatic biliary tract
2. Metastatic or locally advanced (unresectable) disease
3. Adequate organ function; creatinine<1.5xULN, BR<1.5xULN Neut>1.5, Pts>100
4. WHO Performance status 0-2
5. No prior chemotherapy for advanced Cholangiocarcinoma (Prior adjuvant chemotherapy is accepted)
6. Measurable or non-measurable disease
7. Informed consent for study participation and donation of tumour tissue for evaluation of relevant translational endpoints

Exclusion Criteria:

1. Cytotoxic chemotherapy or immunotherapy within 4 weeks prior to enrolment
2. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
3. Known intolerance or hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus)
4. Uncontrolled diabetes mellitus or hyperlipidaemia
5. Patients who have any severe and/or uncontrolled medical conditions
6. Active or uncontrolled severe infection
7. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
8. Severely impaired lung function
9. Patients with a known history of HIV seropositivity
10. Patients who have a history of another primary malignancy (Exceptions include non-melanoma skin cancer, carcinoma in situ of uterine cervix, or any other cancer treated with curative intent without evidence of relapse for more than 2 years)
11. Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes