A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

October 15, 2018 updated by: Aeglea Biotherapeutics

A Phase 2 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents

This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Comprehensive Cancer Center at University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical School
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Age 18 and older
  • Diagnosis of AML or MDS according to the WHO criteria
  • AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens
  • MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMA
  • Has adequate organ function: AST and ALT < 3X the ULN, serum bilirubin < 2X the ULN, serum creatinine of < 2 mg/dL, or a calculated creatinine clearance of > 50 mL/minute
  • ECOG Performance Score of 0 -2
  • Recovered from the effects of any prior systemic therapy, radiotherapy or surgery
  • Willing to use physician approved birth control method

Exclusion Criteria:

  • Current CNS Leukemia
  • Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
  • < 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents
  • Uncontrolled infection
  • Known HIV, hepatitis B or hepatitis C.
  • Other active malignancy that requires therapy
  • If female, is lactating or breast feeding
  • Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AEB1102 (Co-ArgI-PEG) administered via IV weekly.
Co-ArgI-PEG modified human arginase I
Drug: Co-ArgI-PEG modified human arginase I
Other Names:
  • AEB1102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose and Recommended Phase 2 Dose
Time Frame: 4 weeks
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety profile (changes in physical exam, laboratory measures, reported adverse events)
Time Frame: 4 Weeks
changes in physical exam, laboratory measures, reported adverse events
4 Weeks

Collaborators and Investigators

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

Sponsor

Aeglea Biotherapeutics

Investigators

  • Study Director: Jim Joffrion, Aeglea BioTherapeutics, Inc.

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

August 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB1102-100C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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