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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Drug: Co-ArgI-PEG modified human arginase I

• Registration Number: NCT02732184
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Study Start: 2016-08
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Disposition First Submitted: 2018-10-12
• Disposition First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Disposition First Posted: 2018-10-17
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AEB1102 (Co-ArgI-PEG) administered via IV weekly.	Co-ArgI-PEG modified human arginase I	Co-ArgI-PEG modified human arginase I

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose and Recommended Phase 2 Dose	4 weeks	The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Safety profile (changes in physical exam, laboratory measures, reported adverse events)	4 Weeks	changes in physical exam, laboratory measures, reported adverse events

Trial Locations

Locations (10)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States

Comprehensive Cancer Center at University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott & White; 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada