ClarIDHy
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects with Nonresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation
IRAS ID
222996
Contact name
Juan Valle
Contact email
Sponsor organisation
Agios Pharmaceuticals, Inc.
Eudract number
2015-005117-72
Duration of Study in the UK
2 years, 4 months, 0 days
Research summary
This trial is a study of the safety and efficacy of the study drug AG-120 (compared to Placebo) in patients who have been previously treated for Non-resectable or Metastatic Cholangiocarcinoma with a confirmed IDH1 mutation and are not eligible for transplantation, minimal invasive procedures or localised treatment. Non-resectable means the Cholangiocarcinoma is not removable with surgery and Metastatic means the cancer may have spread from its origin.
Patients will go through a pre-screening or screening process where a tumour sample will be taken (or a banked tumour specimen will be used) for confirmation of the IDH1 mutation. There will be a pre-screening or screening consent form to ensure understanding and willingness to participate in the pre-screening or screening process.
Approximately 48 centres around the world will take part in this study, involving approximately 186 patients. The subjects will be randomised to determine whether they receive the AG-120 study drug or placebo. This will be completed on a 2:1 ratio, meaning that around 124 patients will receive study drug and 62 subjects will receive placebo. This study is blinded, which means neither the participant or study doctor will know which study medication the participant will receive. The study drug, AG-120, will be given orally at a dose of 500mg (provided as 2 x 250mg strength tablets). Placebo will be supplied as matched tablets also to be administered orally.
Patients will receive treatment with the study drug or placebo until their disease has progressed, development of any unacceptable toxicity, if a pregnancy is confirmed, if the patient withdraws their consent, the patient has died, or the sponsor ends the study, whichever event occurs first.
This study is being sponsored by Agios. Out of the expected 186 patients, 20 will be taking part from the United Kingdom.REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0330
Date of REC Opinion
24 Aug 2017
REC opinion
Further Information Favourable Opinion