drugset / Trial / NCT02692742

Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia

NCT02692742 ↗

Phase 2 Completed 137 enrolled Myelo Therapeutics GmbH
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses and density of chemotherapy that can be tolerated. The degree and duration of neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule, has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate differentiation of peripheral white blood cells (WBC) and bone marrow cells of the leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is to determine the safety and effectiveness of Myelo001 in preventing or reducing chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due to breast cancer.

Timeline

Start
2016-03
Primary completion
2017-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ingavirin Small molecule 100 mg Oral