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)
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 |
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
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 |