NCT00117039

Brief Summary

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2005

Completed
Last Updated

October 15, 2008

Status Verified

August 1, 2008

First QC Date

June 30, 2005

Last Update Submit

October 14, 2008

Conditions

AnemiaNeoplasms

Keywords

anemiafatigueAranesp®clinical trial

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin maintenance

Secondary Outcomes (2)

  • Quality of Life

  • Changes in measures of work productivity and anemia treatment convenience

Interventions

Aranesp®DRUG

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 (2)

  • Boccia R, Lillie T, Tomita D, Balducci L. The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy-induced anemia. Oncologist. 2007 May;12(5):584-93. doi: 10.1634/theoncologist.12-5-584.

    PMID: 17522247RESULT

  • Boccia R, Malik IA, Raja V, Kahanic S, Liu R, Lillie T, Tomita D, Clowney B, Silberstein P. Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia. Oncologist. 2006 Apr;11(4):409-17. doi: 10.1634/theoncologist.11-4-409.

    PMID: 16614237RESULT

Related Links

MeSH Terms

Conditions

AnemiaNeoplasmsFatigue

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 4, 2005

Study Start

January 1, 2004

Study Completion

April 1, 2005

Last Updated

October 15, 2008

Record last verified: 2008-08