Brief Title
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
Official Title
Phase II Study of RAD001 in Advanced Cholangiocarcinoma
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 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.
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumour control
Secondary Outcome
Overall survival
Condition
Cholangiocarcinoma
Intervention
RAD001
Study Arms / Comparison Groups
RAD001 10mg/d
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
September 2009
Completion Date
March 2012
Primary Completion Date
September 2011
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +61394965763, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00973713
Organization ID
H2009/3522
Study Sponsor
Austin Health
Study Sponsor
, ,
Verification Date
September 2009