Comparable efficacy and safety profiles of daily injection of BK0023 and filgrastim (Neupogen®) in chemotherapy-induced neutropenia: a multinational, multicenter, investigator blind, randomised, parallel group study in women with breast cancer
- Conditions
- Chemotherapy induced NeutropeniaMedDRA version: 9.1Level: LLTClassification code 10029354Term: Neutropenia
- Registration Number
- EUCTR2007-007161-20-BG
- Lead Sponsor
- BIO-KER S.R.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 288
•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
•Absolute neutrophil count < 1.5 x109/L; platelet count < 100 x109/L and
haemoglobin < 10 g/dl
•Received systemic anti-infective treatment within 72h of chemotherapy
•Prior bone marrow or stem cell transplantation
•Total lifetime exposure to doxorubicin > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method