Description:
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.
Title
- Brief Title: A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
- 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 IDs
- ORG STUDY ID:
CAEB1102-100C
- NCT ID:
NCT02732184
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
Interventions
Drug | Synonyms | Arms |
---|
Co-ArgI-PEG modified human arginase I | AEB1102 | AEB1102 (Co-ArgI-PEG) administered via IV weekly. |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
AEB1102 (Co-ArgI-PEG) administered via IV weekly. | Experimental | Co-ArgI-PEG modified human arginase I | - Co-ArgI-PEG modified human arginase I
|
Eligibility Criteria
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)
Maximum Eligible Age: | 90 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose and Recommended Phase 2 Dose |
Time Frame: | 4 weeks |
Safety Issue: | |
Description: | The dose level at which no more than 1/6 patients experiences dose-limiting toxicity |
Secondary Outcome Measures
Measure: | Safety profile (changes in physical exam, laboratory measures, reported adverse events) |
Time Frame: | 4 Weeks |
Safety Issue: | |
Description: | changes in physical exam, laboratory measures, reported adverse events |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Aeglea Biotherapeutics |
Trial Keywords
Last Updated
October 17, 2018