Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol

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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