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

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: placebo; Drug: epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628043

EPO316 JP

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

EPOCH

Experimental group

Treatment:

Drug: epoetin beta

placebo

Placebo Comparator group

Treatment:

Drug: placebo