NCT00628043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

February 24, 2008

Last Update Submit

September 17, 2009

Conditions

Anemia

Keywords

Cancerpatientswithchemotherapyinducedanemia

Outcome Measures

Primary Outcomes (1)

  • The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL

    16 weeks

Secondary Outcomes (3)

  • Change in Hb

    16 weeks

  • Change in FACT- total Fatigue Subscale score (FSS)

    16 weeks

  • Requirement for RBC transfusion

    16 weeks

Study Arms (2)

EPOCH

EXPERIMENTAL
Drug: epoetin beta

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

epoetin betaDRUG

Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks

EPOCH
placeboDRUG

Subcutaneous administration of placebo once-weekly for 12 weeks

placebo

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung cancer or gynecologic cancer patients
  • Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
  • g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
  • years old
  • Performance status: 0 - 2
  • No iron deficiency anemia

You may not qualify if:

  • Red blood cell transfusion within 4 weeks before treatment
  • Erythropoietin therapy within 8 weeks before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chugoku/Shikoku Region

Chugoku/Shikoku, Japan

Location

Chubu Region

Chūbu, Japan

Location

Hokkaido/Tohoku Region

Hokkaido/Tohoku, Japan

Location

Kanto/Koshinetsu Region

Kanto/Koshinetsu, Japan

Location

Kinki/Hokuriku Region

Kinki/Hokuriku, Japan

Location

Kyushu Region

Kyushu, Japan

Location

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yoshito Suzuki

    Chugai Pharmaceutical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 4, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

JP(6)