NCT00148421

Brief Summary

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

First QC Date

June 30, 2005

Last Update Submit

May 13, 2013

Conditions

Anemia

Keywords

Non-myeloid malignancyChemotherapy-induced anemia

Outcome Measures

Primary Outcomes (1)

  • Reduced incidence of transfusions

Secondary Outcomes (1)

  • Change in hemoglobin concentration

Interventions

Darbepoetin alfa and Epoetin 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)

  • 20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.

    PMID: 16710026RESULT

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfaEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

September 8, 2005

Last Updated

May 15, 2013

Record last verified: 2013-05