Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02103478

Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 
This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well as determine the dose for the study's second stage. In the second stage the selected dose will be confirmed and evaluated for clinical activity, including response rate.
Status: 
Recruiting
Study Date: 
Thu, 05/01/2014 to Wed, 06/01/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: ASTX727 Dose Escalation Oral investigational product and approved IV decitabine Other Names: E7727 oral decitabine IV decitabine Drug: ASTX727 Dose Confirmation Randomization cross over design for courses 1 and 2 Other Names: ASTX727 oral (combination of oral E7727 and oral decitabine) IV decitabine