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

Aeglea BioTherapeutics

Status and phase

Completed

Phase 2

Conditions

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Treatments

Drug: Co-ArgI-PEG modified human arginase I

Study type

Interventional

Funder types

Industry

Identifiers

NCT02732184

CAEB1102-100C

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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)