Status:
UNKNOWN
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
Lead Sponsor:
Austin Health
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 treatm...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed adenocarcinoma of gall bladder, intra or extra-hepatic biliary tract
- Metastatic or locally advanced (unresectable) disease
- Adequate organ function; creatinine\<1.5xULN, BR\<1.5xULN Neut\>1.5, Pts\>100
- WHO Performance status 0-2
- No prior chemotherapy for advanced Cholangiocarcinoma (Prior adjuvant chemotherapy is accepted)
- Measurable or non-measurable disease
- Informed consent for study participation and donation of tumour tissue for evaluation of relevant translational endpoints
Exclusion
- Cytotoxic chemotherapy or immunotherapy within 4 weeks prior to enrolment
- Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- Known intolerance or hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus)
- Uncontrolled diabetes mellitus or hyperlipidaemia
- Patients who have any severe and/or uncontrolled medical conditions
- Active or uncontrolled severe infection
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Severely impaired lung function
- Patients with a known history of HIV seropositivity
- 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)
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00973713
Start Date
September 1 2009
End Date
March 1 2012
Last Update
September 9 2009
Active Locations (1)
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1
Austin Health
Melbourne, Victoria, Australia, 3084