Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS
AML
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
1 other identifier
interventional
105
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJune 4, 2018
September 1, 2017
4 years
October 13, 2015
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b:MTD of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS
1 year
Phase 2: Overall response rate of OXi4503 in combination with intermediate-dose cytarabine in subjects with MDS after failure of 1 prior hypomethylating agent (Arm A), and subjects with relapsed and refractory AML after treatment failure of up
2 years
Study Arms (4)
Phase 2 AML
EXPERIMENTALOXi4503 at MTD plus cytarabine 1g/m2/day
Phase 2 MDS
EXPERIMENTALOXi4503 at MTD plus cytarabine 1g/m2/day
OXi4503 dose escalation
EXPERIMENTALMTD for OXi4503 will be determined
OXi4503 + cytarabine dose escalation
EXPERIMENTALMTD of the combination of OXi4503 + cytarbine will be determined
Interventions
Determination of MTD of OXi4503
Determination of MTD of the combination of OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
Related Publications (1)
Johnson SP, Ogunlade O, Lythgoe MF, Beard P, Pedley RB. Longitudinal Photoacoustic Imaging of the Pharmacodynamic Effect of Vascular Targeted Therapy on Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7436-7447. doi: 10.1158/1078-0432.CCR-19-0360. Epub 2019 Sep 24.
PMID: 31551349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
June 4, 2018
Record last verified: 2017-09