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Acute Myelogenous LeukemiaPhase 1/2AMLNCT02576301

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

A Phase 1/2 study testing Phase 1 - OXi4503, Phase 1 - OXi4503 + cytarabine and Phase 2 - OXi4503 + cytarabine in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Mateon Therapeutics at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Phase 1 - OXi4503, Phase 1 - OXi4503 + cytarabine and Phase 2 - OXi4503 + cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
4 sitesUnited States
Study dates
Oct 2015to Oct 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide informed consent
  • ≥ 18 years of age
  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Rachel Couchenour contact

650-635-7000

United States4 sites, 4 recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Christina Cline, RN, 352-273-6840, clcline@ufl.edu

    Christopher Cogle R Cogle, MD

    Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

    Bruck Habtemariam, 310-794-0242, bhabtemariam@mednet.ucla.edu

    Gary Schiller, MD

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Yvonne Dinh, 305-243-9899, y.dinh@med.miami.edu

    Justin Watts, MD

    Recruiting

  • University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

    Michelle Cairns, MA, 913-945-7547, mcairns3@kumc.edu

    Tara Lin, MD

    Recruiting

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Phase 1 - OXi4503, Phase 1 - OXi4503 + cytarabine, Phase 2 - OXi4503 + cytarabine
Keywords
AML, MDS
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase 1 - OXi4503Drug

    Also called CA1P, combretastatin A1-diphosphate

    Determination of MTD of OXi4503

  • Phase 1 - OXi4503 + cytarabineDrug

    Also called CA1P, combretastatin A1-diphosphate

    Determination of MTD of the combination of OXi4503 + cytarabine

  • Phase 2 - OXi4503 + cytarabineDrug

    Also called CA1P, combretastatin A1-diphosphate

    Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML

  • Phase 2 - OXi4503 + cytarabineDrug

    Also called CA1P, combretastatin A1-diphosphate

    Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS

Study groups in NCT02576301
Study groupRoleWhat they receive
Phase 2 AMLExperimentalOXi4503 at MTD plus cytarabine 1g/m2/day
Receives: Drug: Phase 2 - OXi4503 + cytarabine
Phase 2 MDSExperimentalOXi4503 at MTD plus cytarabine 1g/m2/day
Receives: Drug: Phase 2 - OXi4503 + cytarabine
OXi4503 dose escalationExperimentalMTD for OXi4503 will be determined
Receives: Drug: Phase 1 - OXi4503
OXi4503 + cytarabine dose escalationExperimentalMTD of the combination of OXi4503 + cytarbine will be determined
Receives: Drug: Phase 1 - OXi4503 + cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02576301
Sponsor's protocol ID
OX1222
Acronym
AML
Status last verified
Sep 2017
First submitted
13 Oct 2015
Last updated
4 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31551349

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Phase 1 - OXi4503, Phase 1 - OXi4503 + cytarabine and Phase 2 - OXi4503 + cytarabine in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Mateon Therapeutics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rachel Couchenour (650-635-7000), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02576301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.

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