Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02576301

Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML)
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS.

Phase 2 will investigate overall response rate of OXi4503 in combination with intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up to 1 prior chemotherapy regimen (Arm B).

Status: 
Recruiting
Study Date: 
Thu, 10/01/2015 to Sun, 10/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: OXi4503 Determination of MTD of OXi4503 Drug: OXi4503 + cytarabine Determination of MTD of the combination of OXi4503 + cytarabine Drug: OXi4503 + cytarabine Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML Drug: OXi4503 + cytarabine Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS