Condition category
Cancer
Date applied
29/04/2008
Date assigned
22/05/2008
Last edited
30/08/2011
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

Prof Manfred Kaufmann

ORCID ID

Contact details

Universitäts-Frauenklinik
Zentrum für Frauenheilkunde
Theodor-Stern-Kai 7
Frankfurt
60596
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XM22-02-INT

Study information

Scientific title

Acronym

Study hypothesis

The primary objective of this study is dose-finding of a fixed dose of XM22.

Ethics approval

Ethics Committee for Multi-Centric Clinical Trials of the University Hospital Motol, V uvalu 84, 150 06 Praha 5, Czech Republic. Date of approval: 09/04/2008 (ref: EK-279/08)

Study design

Multinational, multicentre, randomised, double-blind, controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Breast cancer

Intervention

Participants will be randomly allocated to the following two arms:
1. Neulasta®, 6 mg, administered subcutaneously once per chemotherapy cycle
2. XM22 administered subcutaneously once per chemotherapy cycle

Intervention type

Drug

Phase

Not Specified

Drug names

Neulasta®, XM22

Primary outcome measures

Duration of severe neutropenia (DSN) in cycle 1

Secondary outcome measures

Incidence of febrile neutropenia (FN) in cycles 1, 2, 3 and 4

Overall trial start date

30/04/2008

Overall trial end date

28/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women aged >= 18 years
2. Signed and dated written informed consent
3. Breast cancer high risk stage II, or stage III or IV
4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
5. Chemotherapy-naïve
6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
7. ANC >= 1.5 x 10^9/L
8. Platelet count >= 100 x 10^9/L
9. Adequate cardiac function (including left ventricular ejection fraction >= 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation)
10. Adequate hepatic function, i.e., alanine aminotransferase (ALT)/aspartate transaminase (AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin <ULN
11. Adequate renal function, i.e., creatinine <1.5 x ULN

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Participation in a clinical trial within 30 days before randomisation
2. Previous exposure to filgrastim, pegfilgrastim, lenograstim, or other granulocyte-colony stimulating factors (G-CSFs) in clinical development
3. Known hypersensitivity to docetaxel
4. Underlying neuropathy of grade 2 or higher
5. Treatment with systemically active antibiotics within 72 hours before chemotherapy
6. Treatment with lithium
7. Chronic use of oral corticosteroids
8. Prior radiation therapy within 4 weeks before randomisation
9. Prior bone marrow or stem cell transplantation
10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix
11. Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint
12. Pregnant or nursing women. Women of child bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.

Recruitment start date

30/04/2008

Recruitment end date

28/02/2009

Locations

Countries of recruitment

Czech Republic, Germany, Hungary, Poland, Romania, Russian Federation, Ukraine

Trial participating centre

Universitäts-Frauenklinik
Frankfurt
60596
Germany

Sponsor information

Organisation

BioGeneriX AG (Germany)

Sponsor details

Janderstrasse 3
Mannheim
68199
Germany
anton.buchner@ratiopharm.de

Sponsor type

Industry

Website

http://www.biogenerix.com

Funders

Funder type

Industry

Funder name

BioGeneriX AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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