Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Immedica Pharma AB
With
Aeglea Biotherapeutics
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
