Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00973713




Registration number
NCT00973713
Ethics application status
Date submitted
8/09/2009
Date registered
9/09/2009
Date last updated
9/09/2009

Titles & IDs
Public title
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
Scientific title
Phase II Study of RAD001 in Advanced Cholangiocarcinoma
Secondary ID [1] 0 0
H2009/3522
Universal Trial Number (UTN)
Trial acronym
RADiChol
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholangiocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RAD001

Experimental: RAD001 10mg/d -


Treatment: Drugs: RAD001
10mg/d
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumour control
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Toxicity
Timepoint [2] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2012
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00973713
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Niall Tebbutt, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61394965763
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00973713