Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Lung cancer or gynecologic cancer patients

• Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration

• 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL

• 20 - 79 years old

• Performance status: 0 - 2

• No iron deficiency anemia

Exclusion Criteria:

• Red blood cell transfusion within 4 weeks before treatment

• Erythropoietin therapy within 8 weeks before treatment