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

NCT02576301 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-06-04

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Mateon Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-31
Completion
2020-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576301 on ClinicalTrials.gov