ClarIDHy: A Phase 3, multicenter, randomized, double-blind of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.

Study Name
ClarIDHy: A Phase 3, multicenter, randomized (people are allocated by chance to receive one of clinical interventions) double-blind (neither the participant nor the investigator know who is receiving AG-120 or the placebo) of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.
ClinicalTrials.gov Identifier (if applicable)
NCT02989857
Study Center
Institution Name
Agios (study sponsor)
Institution Address
88 Sidney Street
City
Cambridge
State
Massachusetts
Zip Code
02139
Phone
(617) 649-8600
Website
http://www.ClarIDHy.com
List additional Institutions (include address, phone number, and website)
Fox Chase Cancer Center, Philadelphia, PA, United States
MD Anderson Cancer Center, Houston, TX, United States
Memorial Sloan Kettering Cancer Center, New York, NY, United States
Sarah Cannon Cancer Center, Nashville, TN, United States
Study Contacts
Principal Investigator
Agios Medical Affairs
P.I. Phone
(844) 633-2332
P.I. Email
medinfo@agios.com
List additional Principal Investigators (include phone number and email)
To find a study near you or to learn more, please contact Agios Medical Affairs at 844-633-2332 ormedinfo@agios.com. Additional information about the ClarIDHy trial is also available at www.ClarIDHy.com.
Study Coordinator
Agios Medical Affairs
Study Coordinator Phone
(844) 633-2332
Study Coordinator Email
medinfo@agios.com
List additional Study Coordinators (include phone number and email)
To learn more, please visit www.ClarIDHy.com.
OVERVIEW – in layman’s terms (150 words max)
ClarIDHy is Phase 3, multicenter, randomized (people are allocated by chance to receive one of clinical interventions) double-blind (neither the participant nor the investigator know who is receiving AG-120 or the placebo) of orally administered AG-120 for patients with advanced cholangiocarcinoma and an IDH1 gene mutation.
Enrollment
186 patients
Study Start Date
12/01/2016
Estimated Completion Date
11/01/2019
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of the the ClarIDHy clinical trial is to test how safe and effective AG-120 is in patients with an IDH1gene mutation in advanced cholangiocarcinoma.
Inclusion Criteria – Patients Must:
  • To be eligible for the ClarIDHy clinical trial, patients must meet certain criteria, including: Be at least 18 years old, have advanced cholangiocarcinoma that cannot be removed by surgery, have an IDH1 gene mutation (testing to find out if the patient has an IDH1 gene mutation will be provided by the clinical trial), have been treated with cancer medicine, but the disease has grown or spread. Please refer towww.ClinicalTrials.gov, identifier NCT02989857, for a complete list of Inclusion Criteria.
Exclusion Criteria – Patients Must NOT:
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • A test to find out if the patient has an IDH1 gene mutation is required before beginning the study. The IDH1 test will be provided by the clinical trial.

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