Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02732184 | A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS | PHASE2 | COMPLETED | 29 | — | — | Aug 1, 2016 | Dec 1, 2017 | Oct 17, 2018 | 10 | United States, Canada |
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| AEB1102 (Co-ArgI-PEG) administered via IV weekly. | EXPERIMENTAL | Co-ArgI-PEG modified human arginase I |
| Name | Type | Description |
|---|---|---|
| Co-ArgI-PEG modified human arginase I | DRUG | - |
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 ...