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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list