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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 : Recruiting
First Posted : October 15, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics

Study Description
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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).


Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Myelodysplastic Syndromes Drug: Phase 1 - OXi4503 Drug: Phase 1 - OXi4503 + cytarabine Drug: Phase 2 - OXi4503 + cytarabine Phase 1 Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Cytarabine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 2 AML
OXi4503 at MTD plus cytarabine 1g/m2/day
 Drug: Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Other Names:
  • CA1P
  • combretastatin A1-diphosphate
Experimental: Phase 2 MDS
OXi4503 at MTD plus cytarabine 1g/m2/day
 Drug: Phase 2 - OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
Other Names:
  • CA1P
  • combretastatin A1-diphosphate
Experimental: OXi4503 dose escalation
MTD for OXi4503 will be determined
 Drug: Phase 1 - OXi4503
Determination of MTD of OXi4503
Other Names:
  • CA1P
  • combretastatin A1-diphosphate
Experimental: OXi4503 + cytarabine dose escalation
MTD of the combination of OXi4503 + cytarbine will be determined
 Drug: Phase 1 - OXi4503 + cytarabine
Determination of MTD of the combination of OXi4503 + cytarabine
Other Names:
  • CA1P
  • combretastatin A1-diphosphate


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide informed consent
  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:

  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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Rachel Couchenour 650-635-7000

Locations
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         
Sponsors and Collaborators
Mateon Therapeutics
More Information
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Responsible Party: Mateon Therapeutics
ClinicalTrials.gov Identifier: NCT02576301     History of Changes
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

Keywords provided by Mateon Therapeutics:
AML
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
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