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

Acute Myeloid Leukemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732184
• Other study ID #: CAEB1102-100C
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: Aeglea Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Co-ArgI-PEG modified human arginase I

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	Comprehensive Cancer Center at University of Michigan	Ann Arbor	Michigan
United States	The Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Baylor Scott & White	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Washington University Medical School	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Aeglea Biotherapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose and Recommended Phase 2 Dose	The dose level at which no more than 1/6 patients experiences dose-limiting toxicity	4 weeks
Secondary	Safety profile (changes in physical exam, laboratory measures, reported adverse events)	changes in physical exam, laboratory measures, reported adverse events	4 Weeks