Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS (AML)

June 1, 2018 updated by: Mateon Therapeutics

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Christopher Cogle R Cogle, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Justin Watts, MD
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center and Medical Pavilion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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: 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 AML
Other Names:
  • CA1P
  • combretastatin A1-diphosphate
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateon Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OX1222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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