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Phase II Study of RAD001 in Advanced Cholangiocarcinoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumour control

Outcome Time Frame:

12 weeks

Safety Issue:



Australia: Human Research Ethics Committee

Study ID:




Start Date:

September 2009

Completion Date:

March 2012

Related Keywords:

  • Cholangiocarcinoma
  • Advanced cholangiocarcinoma
  • Cholangiocarcinoma