Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndromes
In brief
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).
Key facts
- Study ID
- NCT02576301
- Run by
- Mateon Therapeutics
- People needed
- 105
- Starts
- 2015-10-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2018-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
- University of Florida — Gainesville, Florida, United States (enrolling)
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
- University of Kansas Cancer Center and Medical Pavilion — Westwood, Kansas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.