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Brief Title: Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia
Official Title: 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
Study ID: NCT02692742
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Site 20, Aachen, , Germany
Site 16, Aurich, , Germany
Site 21, Dresden, , Germany
Site 26, Dresden, , Germany
Site 05, Erlangen, , Germany
Site 09, Esslingen, , Germany
Site 02, Frankfurt a.M., , Germany
Site 13, Frankfurt a.M., , Germany
Site 01, Friedrichshafen, , Germany
Site 25, Goslar, , Germany
Site 11, Hamburg, , Germany
Site 10, Hannover, , Germany
Site 22, Hannover, , Germany
Site 07, Konstanz, , Germany
Site 29, Lübeck, , Germany
Site 03, Mainz, , Germany
Site 23, Mainz, , Germany
Site 04, Offenbach, , Germany
Site 19, Oldenburg, , Germany
Site 17, Ravensburg, , Germany
Site 24, Rosenheim, , Germany
Site 28, Tübingen, , Germany
Site 12, Westerstede, , Germany
Name: Dirk Pleimes, MD
Affiliation: Myelo Therapeutics GmbH
Role: STUDY_DIRECTOR