NCT00117624

Brief Summary

The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

December 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

December 20, 2007

Conditions

Anemia

Keywords

Non-myeloid malignancyDarbepoetin alfaClinical Trial

Outcome Measures

Primary Outcomes (1)

  • RBC transfusion during the treatment phase

Secondary Outcomes (4)

  • The time to hemoglobin response during the treatment phase

  • The FACT-Fatigue score profile over time

  • The change in hemoglobin

  • Incidence and severity of adverse events

Interventions

darbepoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kotasek D, Canon JL, Mateos MV, Hedenus M, Rossi G, Taylor K. A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating chemotherapy-induced anemia. Curr Med Res Opin. 2007 Jun;23(6):1387-401. doi: 10.1185/030079907X188053. Epub 2007 May 8.

    PMID: 17559735RESULT

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 8, 2005

Study Start

December 1, 2002

Study Completion

December 1, 2003

Last Updated

December 28, 2007

Record last verified: 2007-12