Back to resultsStudy of RAD001 in Advanced Cholangiocarcinoma: RADiChol (RADiChol)
Primary Purpose
Cholangiocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
RAD001
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Advanced cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Austin HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RAD001 10mg/d
Arm Description
Outcomes
Primary Outcome Measures
Tumour control
Secondary Outcome Measures
Overall survival
Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00973713
Brief Title
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
Acronym
RADiChol
Official Title
Phase II Study of RAD001 in Advanced Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Austin Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Advanced cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RAD001 10mg/d
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
Everolimus
Intervention Description
10mg/d
Primary Outcome Measure Information:
Title
Tumour control
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Toxicity
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niall Tebbutt, FRACP
Phone
+61394965763
Email
niall.tebbutt@ludwig.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Effie Roiniotis, RN
Phone
+61394963576
Email
effie.roiniotis@ludwig.edu.au
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Effie Roiniotis, RN
Phone
+61394963576
Email
effie.roiniotis@ludwig.edu.au
First Name & Middle Initial & Last Name & Degree
Niall Tebbutt, FRACP
12. IPD Sharing Statement
Learn more about this trial
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
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