Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C142

Study information

Scientific title

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

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Blinded randomised multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast Cancer

Intervention

1. Filgrastim 5 mg/kg/day 0.3 mg/ml
2. Filgrastim - SD/01 0.6 ml (of a 10 mg/ml solution)

Intervention type

Drug

Phase

Not Specified

Drug names

filgrastim

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1999

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/1999

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Amgen Limited (UK)

Sponsor details

240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom

Sponsor type

Industry

Website

http://www.amgen.com

Funders

Funder type

Industry

Funder name

Amgen (UK)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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