A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AG-120 IN PREVIOUSLY-TREATED PATIENTS WITH NONRESECTABLE OR METASTATIC CHOLANGIOCARCINOMA WITH AN IDH1 MUTATION (clarIDHy)
Study of Drug in Patients with Previously Treated Bile Duct Cancer (Cholangiocarcinoma)
Sponsor: Agios Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAR5645
U.S. Govt. ID: NCT02989857
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This study is designed to evaluate the efficacy and safety of the study drug AG-120 as compared to placebo in patients with advanced cholangiocarcinoma. AG-120 blocks an abnormal form of a protein called IDH1, which is involved in cancer cell metabolism. Abnormal IDH1 causes too much of a substance called 2-HG to be produced. Researchers believe that having too much 2-HG may fuel cancer growth. Patients in this study must have cholangiocarcinoma that contains a mutated form of the IDH1 gene. Patients will be randomly assigned to receive either AG-120 (orally) or placebo. The placebo is a pill that looks exactly like AG-120, but does not contain any AG-120.
This study is closed
Investigator
Susan Bates, MD
Do You Qualify?
Are you 18 years or older? Yes No
Have you been diagnosed with cholangicarcinoma (cancer of the bile ducts)? Yes No
Does your cancer continue to grow despite standard therapy? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162