Chemotherapy induced Neutropenia MedDRA version: 9.1 Level: LLT Classification code 10029354 Term: Neutropenia
Conditions
Interventions
Product Name: BK0023
Pharmaceutical Form: Solution for injection
Trade Name: Neupogen
Pharmaceutical Form: Solution for injection
Sponsors
BIO-KER S.R.L
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women aged =18 years • Subjects willing and able to give written informed consent • Diagnosis of high-risk stage II or stage III/IV breast cancer • Eastern Cooperative Oncology Group (ECOG) performance status = 2 • Subjects chemotherapy naïve or adjuvant therapy only and/or only one chemotherapy regimen for metastatic disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Absolute neutrophil count 240 mg/m2 or epirubicin > 600 mg/m2 • Subject of child bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding • Subject of child bearing potential or partner of subject is not using or refuses to use adequate contraceptive precautions • Previous exposure to G-CSF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the efficacy of BK0023 to Neupogen® with respect to the duration of grade 4 neutropenia, defined as the number of days in which the subjects have an ANC < 0.5 x 109/L, mainly during the 1st chemotherapy cycle, assuming an equivalence range of -1 day, + 1 day.;Secondary Objective: •To demonstrate a comparable safety profile between BK0023 and Neupogen®, in terms of number, quality and severity of adverse events as well as immunogenicity during the 1st – 4th chemotherapy cycles .;Primary end point(s): Primary Efficacy end point: • the duration of grade 4 neutropenia (defined as ANC < 0.5 x109/L) in cycle 1 Efficacy end point: • Incidence of skeletal pain • Changes in laboratory values • Incidence of adverse events • Formation of specific antibodies against BK0023/ Neupogen®. | — |
Countries
Bulgaria
Outcome results
None listed