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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)

This study is currently recruiting participants.
Verified September 2017 by Mateon Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02576301
First Posted: October 15, 2015
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mateon Therapeutics
October 13, 2015
October 15, 2015
September 25, 2017
October 2015
October 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02576301 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS
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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes
  • Drug: Phase 1 - OXi4503
    Determination of MTD of OXi4503
    Other Names:
    • CA1P
    • combretastatin A1-diphosphate
  • Drug: Phase 1 - OXi4503 + cytarabine
    Determination of MTD of the combination of OXi4503 + cytarabine
    Other Names:
    • CA1P
    • combretastatin A1-diphosphate
  • 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 AML
    OXi4503 at MTD plus cytarabine 1g/m2/day
    Intervention: Drug: Phase 2 - OXi4503 + cytarabine
  • Experimental: Phase 2 MDS
    OXi4503 at MTD plus cytarabine 1g/m2/day
    Intervention: Drug: Phase 2 - OXi4503 + cytarabine
  • Experimental: OXi4503 dose escalation
    MTD for OXi4503 will be determined
    Intervention: Drug: Phase 1 - OXi4503
  • Experimental: OXi4503 + cytarabine dose escalation
    MTD of the combination of OXi4503 + cytarbine will be determined
    Intervention: Drug: Phase 1 - OXi4503 + cytarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
October 2020
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Rachel Couchenour 650-635-7000
United States
 
 
NCT02576301
OX1222
No
Not Provided
Plan to Share IPD: Undecided
Mateon Therapeutics
Mateon Therapeutics
Not Provided
Not Provided
Mateon Therapeutics
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP