NCT02732184

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

April 4, 2016

Last Update Submit

October 15, 2018

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Keywords

AMLMDS

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose and Recommended Phase 2 Dose

    The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

    4 weeks

Secondary Outcomes (1)

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

    4 Weeks

Study Arms (1)

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

EXPERIMENTAL

Co-ArgI-PEG modified human arginase I

Drug: Co-ArgI-PEG modified human arginase I

Interventions

Co-ArgI-PEG modified human arginase IDRUG
Also known as: AEB1102
AEB1102 (Co-ArgI-PEG) administered via IV weekly.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Comprehensive Cancer Center at University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Baylor Scott & White

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Jim Joffrion

    Aeglea BioTherapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

CA(3)US(7)