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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Co-ArgI-PEG modified human arginase I
Sponsored by
Aeglea Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, MDS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Comprehensive Cancer Center at University of Michigan
  • Washington University Medical School
  • University Hospitals Case Medical Center
  • The Cleveland Clinic
  • Vanderbilt-Ingram Cancer Center
  • Baylor Scott & White
  • University of Texas Southwestern Medical Center
  • University of Alberta
  • Princess Margaret Cancer Centre
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AEB1102 (Co-ArgI-PEG) administered via IV weekly.

Arm Description

Co-ArgI-PEG modified human arginase I

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose and Recommended Phase 2 Dose
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Secondary Outcome Measures

Safety profile (changes in physical exam, laboratory measures, reported adverse events)
changes in physical exam, laboratory measures, reported adverse events

Full Information

First Posted
April 4, 2016
Last Updated
October 15, 2018
Sponsor
Aeglea Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02732184
Brief Title
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aeglea Biotherapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Keywords
AML, MDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AEB1102 (Co-ArgI-PEG) administered via IV weekly.
Arm Type
Experimental
Arm Description
Co-ArgI-PEG modified human arginase I
Intervention Type
Drug
Intervention Name(s)
Co-ArgI-PEG modified human arginase I
Other Intervention Name(s)
AEB1102
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose and Recommended Phase 2 Dose
Description
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety profile (changes in physical exam, laboratory measures, reported adverse events)
Description
changes in physical exam, laboratory measures, reported adverse events
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Joffrion
Organizational Affiliation
Aeglea BioTherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor Scott & White
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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