Phase 1/2, Multi-centre, Open-label Study of FT-2102
Research type
Research Study
Full title
A Phase 1/2, Multi-centre, Open-label Study of FT-2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome with an IDH1 Mutation.
IRAS ID
226529
Contact name
Árpád Gábór Tóth
Contact email
Sponsor organisation
FORMA Therapeutics, Inc.
Eudract number
2017-001051-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Study 2102-HEM-101 is a phase 1/2, open-label study of FT-2102 as a single agent and in combination with azacitidine or cytarabine in patients with acute myeloid leukemia or myelodysplastic syndrome with IDH1 mutation. This study will be conducted at clinical sites in the US, Canada, UK, Spain, Italy, Germany, France, Australia and South Korea. The Phase 1 portion of the study has been ongoing in the US since November 2015. Available safety and efficacy data collected from the ongoing study is included in the Investigator’s Brochure.
This study is comprised of 3 stages: a phase 1 dose-escalation stage, a phase 1 dose-expansion stage and a phase 2 stage. Single agent FT-2102 dose escalation was initiated in November 2015 evaluating once-daily (QD) doses of 150 and 300 mg, a twice-daily (BID) dose of 150 mg and once daily dose of 150 mg with food to potentially improve bioavailability. BID dosing with food may be explored if indicated. During the course of single agent dose escalation, a parallel escalation arm was initiated for FT-2102 in combination with azacitidine. This combination was initiated following determination of a pharmacodynamically active dose of FT-2102 in the single agent schedule (150 mg QD and150 BID) and is still ongoing at US sites. After dose-escalation is complete for FT-2102 as a single agent and FT-2102 in combination with azacitidine, a cohort of 6 patients will be treated with FT-2102, at the recommended phase 2 dose, in combination with low dose cytarabine.
Once the maximum tolerated dose or the maximum evaluated dose has been identified for the single-agent and combination cohorts, select populations of patients will be enrolled into phase 1 dose expansion cohorts at the selected single agent or combination doses.
In the Phase 2 portion, specific populations of patients with AML/MDS harboring IDH1-R132 mutations will be enrolled to further characterize the safety and efficacy of FT-2102 either as a single agent or in combination with azacitidine at the to be determined recommended phase 2 doses.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0290
Date of REC Opinion
20 Jun 2018
REC opinion
Further Information Favourable Opinion