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Clinical Trials/EUCTR2007-007161-20-BG
EUCTR2007-007161-20-BG
Active, not recruiting
Not Applicable

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

BIO-KER S.R.0 sites288 target enrollmentDecember 30, 2008
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DrugsNeupogen

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
BIO-KER S.R.
Enrollment
288
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 30, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
BIO-KER S.R.

Eligibility 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

Exclusion Criteria

  • •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
  • •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

Outcomes

Primary Outcomes

Not specified

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