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

Anemia Clinical Trial

Official title:

A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628043
• Other study ID #: EPO316 JP
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2008
• Last updated: September 17, 2009
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• epoetin beta
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
• placebo
Subcutaneous administration of placebo once-weekly for 12 weeks

Locations

Country	Name	City	State
Japan	Chubu Region	Chubu
Japan	Chugoku/Shikoku Region	Chugoku/Shikoku
Japan	Hokkaido/Tohoku Region	Hokkaido/Tohoku
Japan	Kanto/Koshinetsu Region	Kanto/Koshinetsu
Japan	Kinki/Hokuriku Region	Kinki/Hokuriku
Japan	Kyushu Region	Kyushu

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL		16 weeks	Yes
Secondary	Change in Hb		16 weeks	No
Secondary	Change in FACT- total Fatigue Subscale score (FSS)		16 weeks	No
Secondary	Requirement for RBC transfusion		16 weeks	No