Efficacy and safety of XM02 compared to filgrastim in patients with breast cancer receiving chemotherapy: A multinational, multicentre, randomised, controlled study
| ISRCTN | ISRCTN02270769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02270769 |
| Secondary identifying numbers | XM02-02-INT |
- Submission date
- 21/05/2008
- Registration date
- 29/05/2008
- Last edited
- 16/08/2011
- 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
Prof Auro del Giglio
Scientific
Scientific
Faculdade de Medicina do ABC
Av. Principe de Gales, 821 - anexo 3
Departamento de Oncologia
Santo André
09060-650
Brazil
Study information
| Study design | Multinational, multicentre, randomised, controlled study with parallel groups. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | XM02 is superior to placebo and equivalent to filgrastim on the duration of severe neutropenia in cycle 1. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 30/12/2004 |
| Completion date | 26/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 350 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 30/12/2004 |
| Date of final enrolment | 26/09/2005 |
Locations
Countries of recruitment
- Belarus
- Brazil
- Chile
- Hungary
- Lithuania
- Poland
- Romania
- Russian Federation
- Slovenia
- South Africa
Study participating centre
Faculdade de Medicina do ABC
Santo André
09060-650
Brazil
09060-650
Brazil
Sponsor information
BioGeneriX AG (Germany)
Industry
Industry
Janderstrasse 3
Mannheim
68199
Germany
| Phone | +49 621 875 5610 |
|---|---|
| heinz.lubenau@biogenerix.com | |
| Website | http://www.biogenerix.com |
"ROR" |
https://ror.org/03xa4xh46 |
Funders
Funder type
Industry
BioGeneriX AG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
