AC220 With 5-Aza or Low Dose Cytarabine | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01892371

AC220 With 5-Aza or Low Dose Cytarabine
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of the Phase 1 part of this clinical research study is to find the highest tolerable dose of AC220 (quizartinib) that can be given with either 5-azacitidine (azacitidine) or cytarabine to patients with AML or MDS.

The goal of the Phase 2 part of the study is to learn if quizartinib with either azacitidine or cytarabine can help to control AML or MDS. The safety of these combinations will also be studied.

Status: 
Recruiting
Study Date: 
Fri, 11/01/2013 to Thu, 11/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Quizartinib Phase I Starting Dose: 60 mg my mouth daily of a 28 day cycle. For the first cycle only, quizartinib administered starting on day 5 of the cycle. All subsequent cycles quizartinib will start concomitantly with AZA or cytarabine. Phase II Starting Dose: Maximum tolerated dose from Phase I. Other Names: AC220 ASP2689 Drug: Cytarabine Phase I Starting Dose: 20 mg subcutaneously twice a day for 10 days of a 28 day cycle as determined by the treating physician. Phase II Starting Dose: Maximum tolerated dose from Phase I. Other Names: Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: AZA Phase I Starting Dose: 75 mg/m2 subcutaneously or intravenously for 7 days of every 28 day cycle (Days 1-7), as determined by the treating physician. Phase II Starting Dose: Maximum tolerated dose from Phase I. Other Names: Vidaza Azacitidine 5-Azacytidine 5-AZA 5-AZC AZA-CR Ladakamycin NSC-102816 Azacytidine