Status:
COMPLETED
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
Lead Sponsor:
Sandoz
Conditions:
Febrile Neutropenia
Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim...
Eligibility Criteria
Inclusion
- Male or female adults (age \> / = 18 years)
- Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
- Planned to receive primary prophylaxis with filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle.
- Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) label.
- Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
- Informed written consent to participate in the study by patients or their legal guardian.
Exclusion
- Patients with myeloid malignancies, with the exception of multiple myeloma.
- Sensitivity to filgrastim biosimilar or any other CSF.
- Hypersensitivity to E. coli-derived proteins.
- Radiotherapy to ≥ 20% of total body bone.
- Infection within two weeks of starting current line of chemotherapy.
- Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
- Patients with willfully negligent nonadherence to their cancer treatment.
- Use of any investigational agent in the 30 days prior to enrollment.
- Women of childbearing potential not using the contraception method(s) described above.
- Women who are breastfeeding.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
1496 Patients enrolled
Trial Details
Trial ID
NCT01459653
Start Date
March 1 2010
End Date
August 1 2013
Last Update
January 11 2016
Active Locations (116)
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1
Sandoz Investigational Site
Innsbruck, Austria
2
Sandoz Investigational Site
Kufstein, Austria
3
Sandoz Investigational Site
Leoben, Austria
4
Sandoz Investigational Site
Deurne, Belgium