Clinical Trial: Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

Brief Summary: This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The standard treatment for metastatic cholangiocarcinoma is combination chemotherapy with gemcitabine and cisplatin. The FDA (the U.S. Food and Drug Administration) has not approved dasatinib for your specific disease (Cholangiocarcinoma) but it has been approved for other uses (Chronic Myeloid Leukemia)


Sponsor: Massachusetts General Hospital

Current Primary Outcome: Objective Response Rate (ORR) [ Time Frame: 8 Weeks ]

RECIST Criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: Baseline, 2 Years ]
  • Overall Survival [ Time Frame: Baseline, 2 Years ]
  • Number of Participants with Adverse Events [ Time Frame: 8 Weeks ]
  • Biologic correlative studies of target inhibition [ Time Frame: 2 Years ]
    Patients will have mandatory core tumor biopsies at baseline, 8 weeks following dasatinib treatment and at the time of progression for those who had either SD or responses for more than 4 months. Tumor biopsies will be tested for changes in phospho-paxillin (Src kinase target), activated beta-catenin, Ki-67 (proliferation) and cleaved-caspase 3 (cell death).


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: April 23, 2015
Date Started: April 2015
Date Completion: September 2022
Last Updated: February 16, 2017
Last Verified: February 2017