NCT02576301

Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS

Ph 1b Dose Escalation Study of OXi4503 as a Single Agent and in Combination With Cytarabine With Subsequent Phase 2 Cohorts for Subjects With Relapsed/Refractory Acute AML and MDS

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Mateon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Phase 1 dose escalation component will assess the safety, PK/PD, and preliminary efficacy of OXi4503 as a single agent in subjects with relapsed/refractory AML and MDS, and the safety and PK/PD of the combination of OXi4503 with intermediate-dose cytarabine in subjects with AML/MDS. Phase 2 will assess the preliminary efficacy of the OXi4503+cytarabine combination in 2 cohorts.

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Phase 1 - OXi4503	Determination of MTD of OXi4503
DRUG	Phase 1 - OXi4503 + cytarabine	Determination of MTD of the combination of OXi4503 + cytarabine
DRUG	Phase 2 - OXi4503 + cytarabine	Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
DRUG	Phase 2 - OXi4503 + cytarabine	Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2015-10-15
• Last updated: 2018-06-04

Locations

4 sites across 1 country: United States