drugset / Trial / NCT03059615

A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS

NCT03059615 ↗

Phase 2 Withdrawn Immune System Key Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles). Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of the drug action.

Timeline

Start
2018-10-25
Primary completion
2020-07-26
Completion
2020-07-26

Outcome

Outcome not reported

Stopped (Enrollment): “No recruitment since initiation”

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Subject Nerofe Peptide 48 mg/m2 Intravenous
Subject Nerofe Peptide 96 mg/m2 Intravenous