drugset / Trial / NCT00327535

A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

NCT00327535

Phase 2 Completed 153 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
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

Indications