NCT00095277

Brief Summary

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2004

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

First QC Date

November 2, 2004

Last Update Submit

March 12, 2009

Conditions

Anemia

Keywords

non-myeloid malignanciesmyelomaAnemia of Cancer

Outcome Measures

Primary Outcomes (1)

  • To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.

Secondary Outcomes (4)

  • Assess efficacy

  • Assess PROs

  • Assess relationship between PROs and hemoglobin concentration

  • Assess safety of dose and frequency

Interventions

Darbepoetin AlfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6):715-24. doi: 10.1634/theoncologist.2007-0241.

    PMID: 18586927RESULT

Related Links

MeSH Terms

Conditions

AnemiaNeoplasms, Plasma Cell

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasms

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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2004

First Posted

November 3, 2004

Study Start

October 1, 2004

Last Updated

March 13, 2009

Record last verified: 2009-03