NCT00144131

Brief Summary

This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_2

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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

First QC Date

September 1, 2005

Last Update Submit

May 22, 2013

Conditions

AnemiaCancer

Keywords

Chemotherapy, AnemiaAranesp®, rHuEPOChemotherapy Induced Anemianon-myeloid malignancyNon-Myeloid MalignanciesChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin (Hb) in chemotherapy induced anemia

Secondary Outcomes (1)

  • Patient-reported outcomes including overall health, fatigue, and daily activities

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 (1)

  • Schwartzberg L, Burkes R, Mirtsching B, Rearden T, Silberstein P, Yee L, Inamoto A, Lillie T. Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial. BMC Cancer. 2010 Oct 25;10:581. doi: 10.1186/1471-2407-10-581.

    PMID: 20973982RESULT

Related Links

MeSH Terms

Conditions

AnemiaNeoplasms

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

August 1, 2005

Last Updated

May 24, 2013

Record last verified: 2013-05