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Trial record 1 of 1 for:    MyeloConcept
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Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia (MyeloConcept)

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ClinicalTrials.gov Identifier: NCT02692742
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Myelo Therapeutics GmbH

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date November 24, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Threshold area over the curve (AOC1) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Threshold area over the curve (AOC3) of ANC: Area below the threshold line (ANC 1.0x10^9/L classified as grade 3 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia [ Time Frame: visit 3 to visit 10 (22 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Change of Threshold Area over the Curve of Absolute Neutrophil Count (ANC): specified by the threshold line defining grade 1 neutropenia and the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Treatment success rate: a) Neutropenia grade ≤2, b) No need for G-CSF rescue therapy, c) No early withdrawal (drop-out). [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Threshold AOC of ANC (AOC4): Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of lymphocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of leukocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of thrombocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Proportion of patients with neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L [ Time Frame: visit 3 to visit 10 (22 days) ]
  • ANC at nadir [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Time to ANC nadir (from start of chemotherapy) [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Time to ANC recovery from grade 3 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Time to ANC recovery from grade 4 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Time to ANC recovery from profound neutropenia (ANC ≥ 0.1x10^9/L), i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥1.5x10^9/L) [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Proportion of patients with rescue therapy [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Proportion of patients developing febrile neutropenia (body temperature ≥38.3°C by single tympanic or oral measurement) and ANC ≤0.5x 10^9/L (Grade 4) [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Proportion of patients with CTX dose reduction and/or delay of CTX cycle 2 [ Time Frame: visit 10 to visit 11 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
  • Change of Threshold Area over the Curve of Absolute Neutrophil Count (ANC): specified by the threshold line defining grade 3 neutropenia and the individual ANC trajectory [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Treatment success rate: a) Neutropenia grade ≤2, b) No need for G-CSF rescue therapy, c) No early withdrawal (drop-out). [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of lymphocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of leukocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Change of Threshold Area over the Curve of thrombocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Rate of neutropenia grade 1 and higher; 3 and higher [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Duration of neutropenia grade 1 and higher; 3 and higher [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Rate of patients requiring rescue therapy [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Rate of patients developing febrile neutropenia [ Time Frame: visit 3 to visit 10 (22 days) ]
  • Rate of patients with chemotherapy dose reduction and/or delay of chemotherapy cycle 2 [ Time Frame: visit 10 to visit 11 (max. 21 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chemotherapy-Induced Neutropenia
  • Myelosuppression
  • Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Myelo001
    Myelo001 100 mg QD
    Intervention: Drug: Myelo001
  • Placebo Comparator: Placebo
    Matching Placebo QD
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2017)
137
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
160
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
  2. Histologically confirmed invasive breast cancer scheduled for neoadjuvant or adjuvant chemotherapy (patient with primary wound healing ([R0])
  3. Already selected for neoadjuvant or adjuvant standard of care EC regimen (Epirubicin 90 mg/m2 BSA (body surface area) + Cyclophosphamide 600 mg/m2 BSA q21d (every 21 days)) (with or without treatment with taxanes afterwards)
  4. Risk of chemotherapy-induced Febrile Neutropenia ≤20% according to ASCO Guidelines (2015)
  5. More than 5 days remaining before the planned initiation of the 1st chemotherapy cycle
  6. Performance status Grade 0-1 (ECOG)
  7. Echocardiography: No contraindication for the scheduled chemotherapy
  8. Haematologic, laboratory and chemistry thresholds at baseline:

    • Absolute neutrophil count (ANC) ≥2,000 cells/ mm3 (≥2.0 x 10/L)
    • Platelet count ≥100,000/mm3 (≥100 x 10exp9/L)
    • Haemoglobin ≥10 g/dL
    • Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)
    • Serum creatinine <2.0 mg/dL
  9. Able to read, understand and willing to sign the informed consent form
  10. Able to undergo the investigations and to follow the Visit schedule

Exclusion Criteria:

  1. Suspected allergy to Myelo001 or its excipients
  2. Prior chemotherapy
  3. Prior or concomitant treatment with radiotherapy
  4. Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) during the first chemotherapy cycle
  5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF)
  6. Currently on or scheduled for primary prophylaxis with antibiotics in the first chemotherapy cycle
  7. History of bone marrow transplantation or stem cell transplant
  8. Administration of another investigational medicinal product / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed.
  9. Already confirmed HIV, hepatitis B or C virus (HBV or HCV) infection
  10. History of somatic disease/condition that may interfere with the objectives of the study
  11. Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
  12. Serious uncontrolled comorbidities
  13. Pregnant or breast-feeding subject
  14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02692742
Other Study ID Numbers  ICMJE CT-MT001-2-2015-1
2015-003610-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Myelo Therapeutics GmbH
Study Sponsor  ICMJE Myelo Therapeutics GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dirk Pleimes, MD Myelo Therapeutics GmbH
PRS Account Myelo Therapeutics GmbH
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP