Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Gary Schiller(ucla)

Description

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).

Official Title

Ph 1b Dose Escalation Study of OXi4503 as a Single Agent and in Combination With Cytarabine With Subsequent Phase 2 Cohorts for Subjects With Relapsed/Refractory Acute AML and MDS

Details

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.

Keywords

Acute Myelogenous Leukemia Myelodysplastic Syndromes AML MDS Preleukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine Combretastatin Phase 1 - OXi4503 Phase 1 - OXi4503 + cytarabine Phase 2 - OXi4503 + cytarabine OXi4503 dose escalation OXi4503 + cytarabine dose escalation

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of Kansas Cancer Center and Medical Pavilion accepting new patients
    Westwood Kansas 66205 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mateon Therapeutics
ID
NCT02576301
Phase
Phase 1/2
Study Type
Interventional
Last Updated