ISRCTN10853057CompletedPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Myelo Therapeutics GmbH
- Enrollment
- 137
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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:
- •8.1. Absolute neutrophil count (ANC) =2,000 cells/ mm3 (=2.0 x 10/L)
- •8.2. Platelet count =100,000/mm3 (=100 x 10exp9/L)
- •8.3. Haemoglobin =10 g/dL
- •8.4. Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)
- •8.5. 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.
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