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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

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Neutropenia Myelosuppression Breast Cancer Drug: Myelo001 Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Myelo001
Myelo001 100 mg QD
Drug: Myelo001
Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment

Placebo Comparator: Placebo
Matching Placebo QD
Drug: Placebo
Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia [ Time Frame: visit 3 to visit 10 (22 days) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Change of Threshold Area over the Curve of lymphocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  4. Change of Threshold Area over the Curve of leukocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  5. Change of Threshold Area over the Curve of thrombocytes [ Time Frame: visit 3 to visit 10 (22 days) ]
  6. 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) ]
  7. 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) ]
  8. ANC at nadir [ Time Frame: visit 3 to visit 10 (22 days) ]
  9. Time to ANC nadir (from start of chemotherapy) [ Time Frame: visit 3 to visit 10 (22 days) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. Proportion of patients with rescue therapy [ Time Frame: visit 3 to visit 10 (22 days) ]
  14. 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) ]
  15. Proportion of patients with CTX dose reduction and/or delay of CTX cycle 2 [ Time Frame: visit 10 to visit 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692742


Locations
Germany
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
Sponsors and Collaborators
Myelo Therapeutics GmbH
Investigators
Study Director: Dirk Pleimes, MD Myelo Therapeutics GmbH

Additional Information:
Responsible Party: Myelo Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT02692742     History of Changes
Other Study ID Numbers: CT-MT001-2-2015-1
2015-003610-25 ( EudraCT Number )
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Myelo Therapeutics GmbH:
Chemotherapy
Chemotherapy-induced Neutropenia
Supportive Care
Myelosuppression
CIN

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases