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

Trial Status: Active

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).

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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Bruck Habtemariam
Phone: 310-794-0242

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: COMPLETED

Kansas

Fairway
University of Kansas Clinical Research Center
Status: CLOSED_TO_ACCRUAL
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Joyce Tungol
Phone: 913-945-7547
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL

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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Mateon Therapeutics

  • Primary ID OX1222
  • Secondary IDs NCI-2016-00143
  • Clinicaltrials.gov ID NCT02576301