Dose-finding of a fixed dose XM22 in patients with breast cancer receiving 4 cycles of chemotherapy versus 6 mg Neulasta®
| ISRCTN | ISRCTN56891934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56891934 |
| Secondary identifying numbers | XM22-02-INT |
- Submission date
- 29/04/2008
- Registration date
- 22/05/2008
- Last edited
- 30/08/2011
- 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 Manfred Kaufmann
Scientific
Scientific
Universitäts-Frauenklinik
Zentrum für Frauenheilkunde
Theodor-Stern-Kai 7
Frankfurt
60596
Germany
Study information
| Study design | Multinational, multicentre, randomised, double-blind, controlled study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The primary objective of this study is dose-finding of a fixed dose of XM22. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Neulasta®, XM22 |
| Primary outcome measure | Duration of severe neutropenia (DSN) in cycle 1 |
| Secondary outcome measures | Incidence of febrile neutropenia (FN) in cycles 1, 2, 3 and 4 |
| Overall study start date | 30/04/2008 |
| Completion date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 30/04/2008 |
| Date of final enrolment | 28/02/2009 |
Locations
Countries of recruitment
- Czech Republic
- Germany
- Hungary
- Poland
- Romania
- Russian Federation
- Ukraine
Study participating centre
Universitäts-Frauenklinik
Frankfurt
60596
Germany
60596
Germany
Sponsor information
BioGeneriX AG (Germany)
Industry
Industry
Janderstrasse 3
Mannheim
68199
Germany
| anton.buchner@ratiopharm.de | |
| 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 |
