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

September 17, 2009 updated by: Chugai Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
        • Chubu Region
      • Chugoku/Shikoku, Japan
        • Chugoku/Shikoku region
      • Hokkaido/Tohoku, Japan
        • Hokkaido/Tohoku region
      • Kanto/Koshinetsu, Japan
        • Kanto/Koshinetsu region
      • Kinki/Hokuriku, Japan
        • Kinki/Hokuriku region
      • Kyushu, Japan
        • Kyushu region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo
Subcutaneous administration of placebo once-weekly for 12 weeks
EXPERIMENTAL: EPOCH
Drug: epoetin beta
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Hb
Time Frame: 16 weeks
16 weeks
Change in FACT- total Fatigue Subscale score (FSS)
Time Frame: 16 weeks
16 weeks
Requirement for RBC transfusion
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Investigators

  • Study Chair: Yoshito Suzuki, Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (ESTIMATE)

March 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPO316 JP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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