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

Sponsor

Aeglea Biotherapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT02732184

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome	Drug: Co-ArgI-PEG modified human arginase I	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 Names: AEB1102

Arm

Intervention/Treatment

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 Names:

AEB1102

Outcome Measures

Primary Outcome Measures

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

Safety profile (changes in physical exam, laboratory measures, reported adverse events) [4 Weeks]
changes in physical exam, laboratory measures, reported adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Michigan	Ann Arbor	Michigan	United States	48109
2	Washington University Medical School	Saint Louis	Missouri	United States	63110
3	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
4	The Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
6	Baylor Scott & White	Dallas	Texas	United States	75246
7	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
8	University of Alberta	Edmonton	Alberta	Canada
9	Princess Margaret Cancer Centre	Toronto	Ontario	Canada
10	Jewish General Hospital	Montreal	Quebec	Canada