Clinical Trials /

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

NCT02732184

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CAEB1102-100C
  • NCT ID: NCT02732184

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
Co-ArgI-PEG modified human arginase IAEB1102AEB1102 (Co-ArgI-PEG) administered via IV weekly.

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.

Trial Arms

NameTypeDescriptionInterventions
AEB1102 (Co-ArgI-PEG) administered via IV weekly.ExperimentalCo-ArgI-PEG modified human arginase I
  • Co-ArgI-PEG modified human arginase I

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)
      
Maximum Eligible Age:90 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose and Recommended Phase 2 Dose
Time Frame:4 weeks
Safety Issue:
Description:The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Secondary Outcome Measures

Measure:Safety profile (changes in physical exam, laboratory measures, reported adverse events)
Time Frame:4 Weeks
Safety Issue:
Description:changes in physical exam, laboratory measures, reported adverse events

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aeglea Biotherapeutics

Trial Keywords

  • AML
  • MDS

Last Updated

August 15, 2017