Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS
(AML Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Mateon Therapeutics
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
Inclusion Criteria
Provide informed consent
≥ 18 years of age
AML that has failed to achieve complete remission or morphologic complete remission or MDS - Marrow blasts must be > 5% and disease failed at least 1 prior hypomethylating agent
+7 more
Participant Groups
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
Cytarabine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cytosar-U for:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
- Meningeal leukemia
🇪🇺 Approved in European Union as Depocyt for:
- Lymphomatous meningitis
🇨🇦 Approved in Canada as Cytosar-U for:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kansas Cancer Center and Medical PavilionWestwood, KS
David Geffen School of Medicine at UCLALos Angeles, CA
University of Miami Sylvester Comprehensive Cancer CenterMiami, FL
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
Mateon TherapeuticsLead Sponsor