Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provide informed consent
  2. ≥ 18 years of age
  3. Phase 1 (dose escalation) subjects must have either:
  4. AML that has failed to achieve complete remission or morphologic complete remission or
  5. MDS - Marrow blasts must be > 5% and disease failed at least 1 prior hypomethylating agent
  6. Phase 2 (expansion) subjects must have either MDS or relapsed/refractory AML
  7. Eastern Cooperative Oncology Group performance status 0, 1, or 2
  8. Total bilirubin ≤ 2
  9. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times upper limit of normal (ULN)
  10. Serum creatinine < 2.5 times ULN
  11. Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
  12. Women of child-bearing potential
  13. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods

Exclusion Criteria

  1. Acute promyelocytic leukemia
  2. Absolute peripheral blood myeloblast count greater than 20,000/mm3
  3. Uncontrolled hypertension
  4. History of congenital long QT syndrome or torsades de pointes
  5. Pathologic bradycardia or heart block
  6. Prolonged baseline QTc
  7. Hiistory of ventricular arrhythmia
  8. Myocardial infarction and/or new ST elevation
  9. Any history of hemorrhagic stroke
  10. Symptomatic congestive heart failure
  11. Major hemorrhagic event within 28 days
  12. Suggestive central nervous system involvement with leukemia
  13. Any open wound
  14. Pregnant and nursing subjects are excluded
  15. Treatment with any anticancer therapy
  16. Treatment with colchicine is excluded.
  17. Psychiatric disorders that would interfere with consent

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2 AML
OXi4503 at MTD plus cytarabine 1g/m2/day
  • Drug: Phase 2 - OXi4503 + cytarabine
    Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
    Other names:
    • CA1P
    • combretastatin A1-diphosphate
Experimental
Phase 2 MDS
OXi4503 at MTD plus cytarabine 1g/m2/day
  • Drug: Phase 2 - OXi4503 + cytarabine
    Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
    Other names:
    • CA1P
    • combretastatin A1-diphosphate
Experimental
OXi4503 dose escalation
MTD for OXi4503 will be determined
  • Drug: Phase 1 - OXi4503
    Determination of MTD of OXi4503
    Other names:
    • CA1P
    • combretastatin A1-diphosphate
Experimental
OXi4503 + cytarabine dose escalation
MTD of the combination of OXi4503 + cytarbine will be determined
  • Drug: Phase 1 - OXi4503 + cytarabine
    Determination of MTD of the combination of OXi4503 + cytarabine
    Other names:
    • CA1P
    • combretastatin A1-diphosphate

Recruiting Locations

University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas 66205
Contact:
Michelle Cairns, MA
913-945-7547
mcairns3@kumc.edu

More Details

Status
Recruiting
Sponsor
Mateon Therapeutics

Study Contact

Rachel Couchenour
650-635-7000

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.