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 and MDS International Foundation

Clinical Trial: NCT02719574

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
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