Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS
NCT ID: NCT02576301
Last Updated: 2018-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2015-10-31
2020-10-31
Brief Summary
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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).
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Detailed Description
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Phase 2 will assess the preliminary efficacy of the OXi4503+cytarabine combination in 2 cohorts.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 2 AML
OXi4503 at MTD plus cytarabine 1g/m2/day
Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Phase 2 MDS
OXi4503 at MTD plus cytarabine 1g/m2/day
Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
OXi4503 dose escalation
MTD for OXi4503 will be determined
Phase 1 - OXi4503
Determination of MTD of OXi4503
OXi4503 + cytarabine dose escalation
MTD of the combination of OXi4503 + cytarbine will be determined
Phase 1 - OXi4503 + cytarabine
Determination of MTD of the combination of OXi4503 + cytarabine
Interventions
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Phase 1 - OXi4503
Determination of MTD of OXi4503
Phase 1 - OXi4503 + cytarabine
Determination of MTD of the combination of OXi4503 + cytarabine
Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 years of age
3. 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
4. Phase 2 (expansion) subjects must have either MDS or relapsed/refractory AML
5. Eastern Cooperative Oncology Group performance status 0, 1, or 2
6. Total bilirubin ≤ 2
7. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times upper limit of normal (ULN)
8. Serum creatinine \< 2.5 times ULN
9. Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
10. Women of child-bearing potential
11. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Mateon Therapeutics
INDUSTRY
Responsible Party
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Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
Countries
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Central Contacts
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Rachel Couchenour
Role: CONTACT
Facility Contacts
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References
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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.
Other Identifiers
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OX1222
Identifier Type: -
Identifier Source: org_study_id
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