A blinded randomised multicentre study to evaluate fixed dose single administration filgrastim-SD/01 vs daily filgrastim as an adjuvant to chemotherapy Stage II or III/IV breast cancer

ISRCTN ISRCTN19151731
DOI https://doi.org/10.1186/ISRCTN19151731
Secondary identifying numbers C142
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
17/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designBlinded randomised multicentre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA blinded randomised multicentre study to evaluate fixed dose single administration filgrastim-SD/01 vs daily filgrastim as an adjuvant to chemotherapy Stage II or III/IV breast cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast Cancer
Intervention1. Filgrastim 5 mg/kg/day 0.3 mg/ml
2. Filgrastim - SD/01 0.6 ml (of a 10 mg/ml solution)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)filgrastim
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1999
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 18 years of age or older
2. Can be chemotherapy naive and/or have no more than one previous regimen of chemotherapy for metastatic disease
3. Blood results within acceptable range
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/1999
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Amgen Limited (UK)
Industry

240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom

Website http://www.amgen.com
ROR logo "ROR" https://ror.org/02gvvc992

Funders

Funder type

Industry

Amgen (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

17/11/2015: No publications found in PubMed.