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Anti-metabolites

Phase 2 AML for Acute Myeloid Leukemia (AML Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Mateon Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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).

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 MDSExperimental Treatment1 Intervention
OXi4503 at MTD plus cytarabine 1g/m2/day
Group II: Phase 2 AMLExperimental Treatment1 Intervention
OXi4503 at MTD plus cytarabine 1g/m2/day
Group III: OXi4503 dose escalationExperimental Treatment1 Intervention
MTD for OXi4503 will be determined
Group IV: OXi4503 + cytarabine dose escalationExperimental Treatment1 Intervention
MTD of the combination of OXi4503 + cytarbine will be determined

Find a Location

Who is running the clinical trial?

Mateon TherapeuticsLead Sponsor
14 Previous Clinical Trials
532 Total Patients Enrolled
~11 spots leftby Sep 2025
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