Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With AML or MDS With an IDH1 Mutation | Aplastic Anemia & MDS International Foundation
Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With AML or MDS With an IDH1 Mutation

Clinical Trial: NCT02719574

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules. Approximately 48 patients will be enrolled in the dose-escalation portion of this study in one or more schedules followed by approximately 14 patients in expansion cohorts

Status: 
Recruiting
Study Date: 
Sat, 04/02/2016 to Thu, 03/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: FT-2102 FT-2102 will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level Drug: Azacitidine azacitidine will be administered per site's standard of care