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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Aeglea Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Aeglea Biotherapeutics
ClinicalTrials.gov Identifier:
NCT02732184
First received: April 4, 2016
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Co-ArgI-PEG modified human arginase I Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Aeglea Biotherapeutics:

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


Estimated Enrollment: 58
Study Start Date: August 2016
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02732184

Contacts
Contact: Shannon Lewis Berlin 1-855-509-9921 clinical@aegleabio.com

Locations
United States, Michigan
Comprehensive Cancer Center at University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: D'Andra Featherstone         
Principal Investigator: Dale Bixby, MD         
United States, Missouri
Washington University Medical School Recruiting
St Louis, Missouri, United States, 63110
Contact: Ryan Monahan         
Principal Investigator: Geoffrey Uy, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mary Ann Draves         
Principal Investigator: Benjamin Tomlinson, MD         
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jaime Fensterl         
Principal Investigator: Hetty Carraway, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shireen Williams         
Principal Investigator: Michael Savona, MD         
United States, Texas
Baylor Scott & White Recruiting
Dallas, Texas, United States, 75246
Contact: Sergio Padilla         
Principal Investigator: Yair Levy, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Joyce Bolluyt         
Principal Investigator: Robert Collins, MD         
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada
Contact: Lori Rackel         
Principal Investigator: Joseph Brandwein, MD         
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Nishita Parekh         
Principal Investigator: Aaron Schimmer, MD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Vivianne Wong         
Principal Investigator: Sarit Assouline, MD         
Sponsors and Collaborators
Aeglea Biotherapeutics
Investigators
Study Director: Andrew Dorr, MD Aeglea Biotherapeutics, Inc.
  More Information

Responsible Party: Aeglea Biotherapeutics
ClinicalTrials.gov Identifier: NCT02732184     History of Changes
Other Study ID Numbers: CAEB1102-100C
Study First Received: April 4, 2016
Last Updated: February 7, 2017

Keywords provided by Aeglea Biotherapeutics:
AML
MDS

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

ClinicalTrials.gov processed this record on June 22, 2017