A test in female patients with breast cancer to probably reduce side effects on blood cells by the planned chemotherapy and to collect data for medical research and drug development on the safety, possible benefits and distribution of an experimental drug called Myelo001 in comparison to a standard treatment.

A randomised, double-blind, placebo-controlled, parallel-design, multi-centre 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 - MyeloConcept

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003610-25-DE

Enrollment

130

Registered

2015-10-05

Start date

2015-12-09

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced neutropenia (CIN) MedDRA version: 20.0 Level: PT Classification code 10072806 Term: Chemotherapy toxicity attenuation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Dicarbamine Product Name: Myelo001 Pharmaceutical Form: Tablet INN or Proposed INN: Imidazolyl ethanamide pentandioic acid Other descriptive name: VITAGLUTAM Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients must meet ALL of the following 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 CTX or adjuvant CTX (patient with primary wound healing ([R0]) 3. Already selected for neoadjuvant or adjuvant standard of care poly-chemotherapy regimen containing anthracyclines in combination with cyclophosphamide (with or without follow-up treatment with taxanes) defined as EC standard regimen 4. Risk of CTX induced FN =20% according to ASCO guidelines (2015) 5. More than 5 days remaining before the planned initiation of the 1st CTX cycle (d1/c1) to allow initiation of IMP on d-5/c1 6. Performance status Grade 0-1 (ECOG) 7. Echocardiography: No contraindication for the scheduled CTX 8. Haematologic and chemistry thresholds at baseline: • Absolute neutrophil count (ANC) =2,000 cells/ mm3 (=2.0 x 10^9/L) • Platelet count =100,000/mm3 (=100 x 10^9/L) • Haemoglobin =10 g/dL • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: A patient will be excluded from participation in the trial, if one or more of the following exclusion criteria are identified: 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) for the first CTX cycle 5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF) for the first CTX cycle 6. Currently on or scheduled for primary prophylaxis with antibiotics for the first CTX cycle 7. History of bone marrow transplantation or stem cell transplant 8. Administration of another IMP / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed 9. Already confirmed HIV, 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of repeated doses of Myelo001 100 mg tablets taken once per day (QD) per os (p.o.) to reduce chemotherapy induced neutropenia (CIN) in patients receiving chemotherapy for the treatment of breast cancer ;Secondary Objective: To investigate: Efficacy to reduce chemotherapy-induced myelosuppression White blood cell (WBC) population changes Pharmacokinetics (PK) of Myelo001 Safety parameters;Primary end point(s): Primary variables (Proof of Concept): 1 Primary endpoint: Threshold area over the curve (AOC) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory, in the study period of d1/c1 to d22/c1 2 Co-primary endpoint: 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, in the study period of d1/c1 to d22/c1 3 Co-primary endpoint: Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia in the study period of d1/c1 to d22/c1 ;Timepoint(s) of evaluation of this end point: Frequent blood counts in the study period between day1/cycle1 to day22/cycle1	—

Measure

Time frame

Main Objective: To assess the efficacy of repeated doses of Myelo001 100 mg tablets taken once per day (QD) per os (p.o.) to reduce chemotherapy induced neutropenia (CIN) in patients receiving chemotherapy for the treatment of breast cancer ;Secondary Objective: To investigate: Efficacy to reduce chemotherapy-induced myelosuppression White blood cell (WBC) population changes Pharmacokinetics (PK) of Myelo001 Safety parameters;Primary end point(s): Primary variables (Proof of Concept): 1 Primary endpoint: Threshold area over the curve (AOC) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory, in the study period of d1/c1 to d22/c1 2 Co-primary endpoint: 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, in the study period of d1/c1 to d22/c1 3 Co-primary endpoint: Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia in the study period of d1/c1 to d22/c1 ;Timepoint(s) of evaluation of this end point: Frequent blood counts in the study period between day1/cycle1 to day22/cycle1

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Secondary

Measure	Time frame
Secondary end point(s): 1 Secondary variables Treatment success rate will fulfill all of the following criteria: a) Neutropenia Grade = 3 b) No need for G-CSF / GM-CSF rescue therapy c) No early withdrawal (drop-out) Evaluation: d1/c1 to d22/c1 or drop-out or until one day post administration of rescue medication, whichever occurs first. Treatment failures are subjects not reaching any of the three criteria 2 Threshold AOC of ANC: Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory during study period of d1/c1 to d22/c1 3 Threshold AOC of lymphocytes: Area below the threshold line (classified as grade 1) and above the individual absolute lymphocyte count trajectory during study period of d1/c1-d22/c1 4 Threshold AOC of leukopenia: Area below the threshold line (classified as grade 1) and above the individual absolute leukocyte count trajectory during the study period of d1/c1 to d22/c1 5 Threshold AOC of thrombocytes: Area below the threshold line (classified as grade 1) and above the individual absolute thrombocyte count trajectory during study period d1/c1 to d22/c1 6 Rate of neutropenia grade 1 and higher; 3 and higher, 4, and ANC =0.1x 10^9/L 7 Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC =0.1x 10^9/L 8 ANC at nadir 9 Time to ANC nadir (from start of chemotherapy) 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) 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) 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) 13 Rate of patients with rescue therapy during study period d1/c1 to d22/c1 14 Rate of patients developing febrile neutropenia (body temperature =38.3°C by single tympanic or oral measurement) and ANC	—

Measure

Time frame

Secondary end point(s): 1 Secondary variables Treatment success rate will fulfill all of the following criteria: a) Neutropenia Grade = 3 b) No need for G-CSF / GM-CSF rescue therapy c) No early withdrawal (drop-out) Evaluation: d1/c1 to d22/c1 or drop-out or until one day post administration of rescue medication, whichever occurs first. Treatment failures are subjects not reaching any of the three criteria 2 Threshold AOC of ANC: Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory during study period of d1/c1 to d22/c1 3 Threshold AOC of lymphocytes: Area below the threshold line (classified as grade 1) and above the individual absolute lymphocyte count trajectory during study period of d1/c1-d22/c1 4 Threshold AOC of leukopenia: Area below the threshold line (classified as grade 1) and above the individual absolute leukocyte count trajectory during the study period of d1/c1 to d22/c1 5 Threshold AOC of thrombocytes: Area below the threshold line (classified as grade 1) and above the individual absolute thrombocyte count trajectory during study period d1/c1 to d22/c1 6 Rate of neutropenia grade 1 and higher; 3 and higher, 4, and ANC =0.1x 10^9/L 7 Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC =0.1x 10^9/L 8 ANC at nadir 9 Time to ANC nadir (from start of chemotherapy) 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) 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) 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) 13 Rate of patients with rescue therapy during study period d1/c1 to d22/c1 14 Rate of patients developing febrile neutropenia (body temperature =38.3°C by single tympanic or oral measurement) and ANC

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Countries

Germany

Contacts

Public ContactProject Management

Myelo Therapeutics GmbH

clinicaltrials@myelotherapeutics.com+4935121927312

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026