Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Breast Neoplasms

Neutropenia

Breast Diseases

Skin Diseases

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Epirubicin

Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Myelo001

Placebo

Dirk Pleimes, MD

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.

Phase IIa study, 1:1 randomized, double-blind, placebo-controlled, parallel-design, multi-center study. Each breast cancer patient will be randomly assigned into one of two treatment arms receiving either Myelo001 or placebo as a tablet. Investigational medicinal product is taken as supportive care for 23 consecutive days during chemotherapy treatment. Hematologic and safety parameters as well as actual begin and doses of following chemotherapy cycles will be assessed. A single primary variable will be analyzed with test statistics based on frequent absolute neutrophil measurements. Additionally, in a subgroup of patients biomarkers and pharmacokinetics of Myelo001 will be investigated.

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

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Center Study to Investigate the Efficacy To Reduce Chemotherapy-Induced Neutropenia (CIN), Effects on the Haematopoietic System, Safety and Pharmacokinetics of Myelo001 in Patients Receiving Adjuvant or Neoadjuvant Chemotherapy for the Treatment Of Breast Cancer

Myelo Therapeutics GmbH

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia	NCT02692742	Chemotherapy-In... Myelosuppressio... Breast Cancer	Myelo001 Placebo	18 Years -	Myelo Therapeutics GmbH
Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia	NCT02692742	Chemotherapy-In... Myelosuppressio... Breast Cancer	Myelo001 Placebo	18 Years -	Myelo Therapeutics GmbH

Spots Global Cancer Trial Database for myelo001

Every month we try and update this database with for myelo001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myelo001

Every month we try and update this database with for myelo001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myelo001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.