Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02193958

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with high-risk MDS/CMML who have relapsed or are refractory to prior therapy; Cohort 2 will include subjects with AML who have relapsed or are refractory to prior therapy or are ≥ 60 hears of age and not candidates for other therapies.

Status: 
Recruiting
Study Date: 
Tue, 07/01/2014 to Sat, 04/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: FF-10501-01 FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. Other Names: Single Group Assignment Drug FF-10501-01