Clinical Trial: Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II Single Arm Study to Evaluate the Safety and Efficacy of RAD001 as Monotherapy in Treatment naïve Advanced Cholangiocarcinoma

Brief Summary: The purpose of this study is to determine whether everolimus is effective in the treatment of patients with advance cholangiocarcinoma.

Detailed Summary: Cholangiocarcinoma is one of the most common cause of cancer death in Thailand. Patients with cholangiocarcinoma are often diagnosed at advanced stage. Palliative therapeutic approaches consisting of percutaneous and endoscopic biliary drainage have usually been used for these patients, since there is no effective chemotherapeutic treatment for this type of cancer. Activation of the phosphoinositide-3-kinase (PI3K)/Akt/mTOR signaling pathway is frequently found in cholangiocarcinoma cells. It has been suggested to be a key step leading to the progression of cholangiocarcinoma. In this study, the investigators hypothesize that inhibition of mTOR may be useful in treating cholangiocarcinoma.
Sponsor: Ratchavithi Hospital

Current Primary Outcome: progression free survival in cholangiocarcinoma patients whom treated with everolimus [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: overall survival rate [ Time Frame: Two years ]

Overall survival is defined as the time from dater of start of treatment to date of death due to any cause.


Original Secondary Outcome: Same as current

Information By: Ratchavithi Hospital

Dates:
Date Received: January 31, 2012
Date Started: January 2012
Date Completion: June 2014
Last Updated: February 2, 2012
Last Verified: January 2012