AG120_C_009
Research type
Research Study
Full title
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
IRAS ID
224823
Contact name
Eduardo Olavarria
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier
Eudract number
2016-004907-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
119341, IND Number
Duration of Study in the UK
5 years, 0 months, days
Research summary
This trial is a study of the efficacy of AG120 in combination with Azacitidine (compared to Azacitidine in combination with placebo) in participants (over 18 years old) who have previously untreated Acute Myeloid Leukaemia (AML) with an IDH1 mutation.
Participants will go through a pre-screening or screening process where a bone marrow aspirate sample and/or a peripheral blood sample will be used for confirmation of the IDH1 mutation. There will be a pre-screening and/or screening consent form to ensure understanding and willingness to participate in the pre-screening and/or screening process.
Approximately 180 centres in 19 countries around the world will take part in this study, involving approximately 392 participants. For the participants who are eligible to take part in the study, they will be randomised to determine whether they receive the AG-120 study drug or placebo. They will be randomised to determine whether they receive the AG120 study drug or placebo in combincation with a recognised standard baseline chemotherapy treatment (Azacytidine) currently used for such patients. This study is blinded, which means neither the participant or study doctor will know which study medication the participant will receive.
Subjects should continue to receive study treatment until disease relapse, disease progression, treatment failure, development of an unacceptable toxicity, confirmed pregnancy, withdrawal of consent, death, or End of Study- whichever occurs first.The study drug, AG-120, will be given orally at a dose of 500mg (provided as 2 x 250mg strength tablets every 24 hours). Placebo will be supplied as matched tablets also to be administered orally. Azacitidine will be administered subcutaneously (SC) or intravenously (IV) at a dose of 75mg a day.
This study is being sponsored by Agios. Out of the expected 392 patients, 16 will be taking part from the United Kingdom.REC name
London - South East Research Ethics Committee
REC reference
17/LO/1500
Date of REC Opinion
12 Jan 2018
REC opinion
Further Information Favourable Opinion