Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML)
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ClinicalTrials.gov Identifier: NCT02576301 |
Recruitment Status : Unknown
Verified September 2017 by Mateon Therapeutics.
Recruitment status was: Recruiting
First Posted : October 15, 2015
Last Update Posted : June 4, 2018
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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).
Condition or disease | Intervention/treatment | Phase |
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Acute Myelogenous Leukemia Myelodysplastic Syndromes | Drug: Phase 1 - OXi4503 Drug: Phase 1 - OXi4503 + cytarabine Drug: Phase 2 - OXi4503 + cytarabine | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | October 2019 |
Estimated Study Completion Date : | October 2020 |

Arm | Intervention/treatment |
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Experimental: Phase 2 AML
OXi4503 at MTD plus cytarabine 1g/m2/day
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Drug: Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Other Names:
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Experimental: Phase 2 MDS
OXi4503 at MTD plus cytarabine 1g/m2/day
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Drug: Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
Other Names:
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Experimental: OXi4503 dose escalation
MTD for OXi4503 will be determined
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Drug: Phase 1 - OXi4503
Determination of MTD of OXi4503
Other Names:
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Experimental: OXi4503 + cytarabine dose escalation
MTD of the combination of OXi4503 + cytarbine will be determined
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Drug: Phase 1 - OXi4503 + cytarabine
Determination of MTD of the combination of OXi4503 + cytarabine
Other Names:
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- Phase 1b:MTD of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS [ Time Frame: 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 [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide informed consent
- ≥ 18 years of age
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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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576301
Contact: Rachel Couchenour | 650-635-7000 |
United States, California | |
David Geffen School of Medicine at UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Bruck Habtemariam 310-794-0242 bhabtemariam@mednet.ucla.edu | |
Principal Investigator: Gary Schiller, MD | |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Christina Cline, RN 352-273-6840 clcline@ufl.edu | |
Principal Investigator: Christopher Cogle R Cogle, MD | |
University of Miami Sylvester Comprehensive Cancer Center | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Yvonne Dinh 305-243-9899 y.dinh@med.miami.edu | |
Principal Investigator: Justin Watts, MD | |
United States, Kansas | |
University of Kansas Cancer Center and Medical Pavilion | Recruiting |
Westwood, Kansas, United States, 66205 | |
Contact: Michelle Cairns, MA 913-945-7547 mcairns3@kumc.edu | |
Principal Investigator: Tara Lin, MD |
Responsible Party: | Mateon Therapeutics |
ClinicalTrials.gov Identifier: | NCT02576301 |
Other Study ID Numbers: |
OX1222 |
First Posted: | October 15, 2015 Key Record Dates |
Last Update Posted: | June 4, 2018 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
AML MDS |
Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Neoplasms Leukemia Neoplasms by Histologic Type Cytarabine Combretastatin Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |