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Spots Global Cancer Trial Database for Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia

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Trial Identification

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

Interventions

Myelo001
Placebo

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Dirk Pleimes, MD

Affiliation: Myelo Therapeutics GmbH

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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