Condition category
Cancer
Date applied
21/05/2008
Date assigned
29/05/2008
Last edited
16/08/2011
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 Auro del Giglio

ORCID ID

Contact details

Faculdade de Medicina do ABC
Av. Principe de Gales
821 - anexo 3
Departamento de Oncologia
Santo André
09060-650
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XM02-02-INT

Study information

Scientific title

Acronym

Study hypothesis

XM02 is superior to placebo and equivalent to filgrastim on the duration of severe neutropenia in cycle 1.

Ethics approval

Romania: National Ethics Committee of Medicamentului Student Clinic (Comisia Nationala de Etica pentru Studiul Clinic al Medicamentului), Av. Sanatescu Str. No 48, Sect. 1, Bucharest, Date of approval: 19/05/2004 (No 1165)
Hungary: Ethics Committee for Clinical Pharmacology, Medical Research Council, Arany J.u. 6-8, H-1051 Budapest. Date of approval: 16/06/2004 (ref: 22972-1/2004-1017EKL)
Lithuania: Lietuvos Bioethics Committee (Lietuvos Bioetikos Komitetas), Kodas 8871059, Vilniaus g. 33-230, LT-2001. Date of approval: 01/06/2004 (ref: 2004-06-02 Nr. 19/3)
Russia: Ethics Committee at the Federal Body of Quality, Efficacy and Safety Control of Medicinal Remedies, 8, Petrovsky Bulvar, Building 1, 103051 Moscow. Date of approval: 16/06/2004 (ref: 2573)
Slovenia: Committee of the Republic of Slovenia for Medical Ethics. Date of approval: 22/06/2004 (ref: 55/06/04)
South Africa: Ethics Committee of the University of the Free State, Kellner Street, Bloemfontein 9301. Date of approval: 16/02/2005 (ref: No ETOVS Nr. 71/04)

Belarus, Chile, Poland: Centres received ethics approval before recruiting participants.

Study design

Multinational, multicentre, randomised, controlled study with parallel groups.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer treated by myelotoxic chemotherapy

Intervention

Arm 1: XM02, 5 µg/kg body weight/day subcutaneously (s.c.)
Arm 2: Filgrastim, 5 µg/kg body weight/day s.c.
Arm 3: Placebo, 5 µg/kg body weight/day s.c.

The study drug/placebo was administered in each cycle of chemotherapy daily from day 2 (24 hours after chemotherapy) to maximum day 15, minimum 5 days. Study drug was stopped as soon as ANC >10 x 10^9/L was reached.

Intervention type

Drug

Phase

Not Specified

Drug names

filgrastim

Primary outcome measures

Duration of severe neutropenia in cycle 1

Secondary outcome measures

1. Secondary efficacy endpoints:
1.1. Incidence of observed febrile neutropenia (FN) (observed FN defined as body temperature of >38.5°C for more than 1 hour, measured axillary with a calibrated standard device, and ANC <0.5 x 10^9/L, both measured on the same day) and of protocol defined FN (intake of systemic antibiotics) by cycle and across all cycles
1.2. Duration of severe neutropenia in cycles 2 to 4
1.3. Depth of ANC nadir in cycles 1 to 4
1.4. Times to ANC recovery in cycles 1 to 4
1.5. Mortality

2. Safety endpoints, determined at the beginning and at the end of each chemotherapy cycle until day 85, antibody determination until day 180:
2.1. Adverse events (AEs)
2.3. Safety laboratory assessment
2.4. Physical examination
2.5. Injection site reactions
2.6. Vital signs
2.7. Eastern Cooperative Oncology Group (ECOG) performance
2.8. Immunogenicity (development of antibodies against study drug)

Other:
3. Pharmacokinetics in a subset of patients

Overall trial start date

30/12/2004

Overall trial end date

26/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed and dated written informed consent
2. Age above or equal 18 years, both males and females
3. Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC])
4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy (CTX) for their breast cancer disease
5. CTX naïve
6. Eastern Cooperative Oncology Group (ECOG) performance status below or equal 2
7. Absolute neutrophil count (ANC) above or equal 1.5 x 10^9/L
8. Platelet count above or equal 100 x 10^9/L
9. Adequate cardiac function (including left ventricular ejection fraction above or equal 50% as assessed by echocardiography within 4 weeks prior to randomisation)
10. Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase (AP) <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

350

Participant exclusion criteria

1. Participation in a clinical trial within 30 days before randomisation
2. Previous exposure to filgrastim, pegfilgrastim or lenograstim
3. Known hypersensitivity to docetaxel
4. Underlying neuropathy of grade 2 or higher
5. Treatment with systemically active antibiotics within 72 hours before CTX
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 could affect the safety of the patient or the evaluation of any study endpoint
12. Pregnant or nursing women were excluded. Women of child-bearing potential had to agree to use a chemical or barrier contraceptive during the treatment period.

Recruitment start date

30/12/2004

Recruitment end date

26/09/2005

Locations

Countries of recruitment

Belarus, Brazil, Chile, Hungary, Lithuania, Poland, Romania, Russian Federation, Slovenia, South Africa

Trial participating centre

Faculdade de Medicina do ABC
Santo André
09060-650
Brazil

Sponsor information

Organisation

BioGeneriX AG (Germany)

Sponsor details

Janderstrasse 3
Mannheim
68199
Germany
+49 621 875 5610
heinz.lubenau@biogenerix.com

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