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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02732184
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
Aeglea Biotherapeutics

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Co-ArgI-PEG modified human arginase I Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 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 Start Date : August 2016
Primary Completion Date : December 2017
Study Completion Date : December 2017

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 Name: AEB1102

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Safety profile (changes in physical exam, laboratory measures, reported adverse events) [ Time Frame: 4 Weeks ]
    changes in physical exam, laboratory measures, reported adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732184

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

Responsible Party: Aeglea Biotherapeutics
ClinicalTrials.gov Identifier: NCT02732184     History of Changes
Other Study ID Numbers: CAEB1102-100C
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by Aeglea Biotherapeutics:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions