drugset / Trial / NCT03516760
Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia
Phase 1
Terminated
36 enrolled
AvenCell Europe GmbH
GCP-Service International Ltd. & Co. KG · collab
NaSequentialOpen-labelTreatment
Summary
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM333 in patients with acute myeloid leukemia (AML). This AML was relapsed after previous therapy or was refractory to the standard therapy.
Timeline
- Start
- 2018-04-11
- Primary completion
- 2022-06-14
- Completion
- 2022-06-14
Outcome
Outcome not reported
Stopped: “The actions and measures to be taken to restart the trial could not be implemented which made the premature termination inevitability.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GEM333 | Unknown | — | Intravenous |