NCT00973713

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

September 8, 2009

Last Update Submit

September 8, 2009

Conditions

Cholangiocarcinoma

Keywords

Advanced cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Tumour control

    12 weeks

Secondary Outcomes (2)

  • Overall survival

    2 years

  • Toxicity

    2 years

Study Arms (1)

RAD001 10mg/d

EXPERIMENTAL
Drug: RAD001

Interventions

RAD001DRUG

10mg/d

Also known as: Everolimus
RAD001 10mg/d

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Central Study Contacts

Niall Tebbutt, FRACP

CONTACT

+61394965763niall.tebbutt@ludwig.edu.au

Effie Roiniotis, RN

CONTACT

+61394963576effie.roiniotis@ludwig.edu.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

AU(1)