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Completed

NCT Number: NCT02732184

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Co-ArgI-PEG modified human arginase I

Drug

Other names: AEB1102

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aeglea Biotherapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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