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

NCT02692742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2017-11-24

No results posted yet for this study

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.

Conditions

  • Chemotherapy-Induced Neutropenia
  • Myelosuppression
  • Breast Cancer

Interventions

DRUG

Myelo001

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Myelo Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Dirk Pleimes, MD · Myelo Therapeutics GmbH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692742 on ClinicalTrials.gov