drugset / Trial / NCT00327535
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
RandomizedParallel-groupOpen-labelTreatment
Summary
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 2.25 ug/kg | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 6.75 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 6.3 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 9 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 12 ug/kg | Subcutaneous |