A Phase 1b Dose Escalation Study of OXi4503 as a Single Agent and in Combination with Cytarabine with Subsequent Combination Phase 2 Cohorts for Subjects with Relapsed/Refractory Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS)
Purpose
Phase 1: Determine the maximum tolerated dose (MTD) of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS. Phase 2: Determine the overall response rate of OXi4503 in combination with intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating agent and 2) subjects with relapsed and refractory AML after treatment failure of up to 1 prior chemotherapy regimen
Inclusion Criteria:
- Provide informed consent
- ≥ 18 years of age
-
Phase 1 (dose escalation) subjects must have either:
- 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
- Phase 2 (expansion) subjects must have either MDS or relapsed/refractory AML
- Eastern Cooperative Oncology Group performance status 0, 1, or 2
- Total bilirubin ≤ 2
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times upper limit of normal (ULN)
- Serum creatinine < 2.5 times ULN
- Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
- Women of child-bearing potential
- Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods
Exclusion Criteria:
- Acute promyelocytic leukemia
- Absolute peripheral blood myeloblast count greater than 20,000/mm3
- Uncontrolled hypertension
- History of congenital long QT syndrome or torsades de pointes
- Pathologic bradycardia or heart block
- Prolonged baseline QTc
- Hiistory of ventricular arrhythmia
- Myocardial infarction and/or new ST elevation
- Any history of hemorrhagic stroke
- Symptomatic congestive heart failure
- Major hemorrhagic event within 28 days
- Suggestive central nervous system involvement with leukemia
- Any open wound
- Pregnant and nursing subjects are excluded
- Treatment with any anticancer therapy
- Treatment with colchicine is excluded.
- Psychiatric disorders that would interfere with consent
Keywords
Acute myeloid leukemia, Myelodysplastic Syndromes (MDS), maximum tolerated dose, chemotherapy, cancerPrincipal Investigator
Christopher R Cogle, M.D.Department
Contact Information
Christopher.Cogle@medicine.ufl.edu
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