Chemotherapy Related Anemia

May 9, 2013 updated by: Amgen

A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with a non-myeloid malignancy
  • Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
  • Screening hemoglobin concentration less than or equal to 11.0g/dL
  • ECOG performance status of 0 to 2
  • Adequate renal and liver function

Exclusion Criteria:

  • History of seizure disorder
  • Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
  • More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Darbepoetin alfa SC
Drug: Darbepoetin alfa SC
Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
Experimental: Darbepoetin alfa IV
Drug: Darbepoetin alfa IV
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Time Frame: from baseline to the end of treatment period (EOTP)
from baseline to the end of treatment period (EOTP)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
Time Frame: throughout study
throughout study
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
Time Frame: from baseline to week 7 and from week 7 to EOTP
from baseline to week 7 and from week 7 to EOTP
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
Time Frame: during the treatment period
during the treatment period
Time to and percentage of subjects with a hemoglobin response during the treatment period
Time Frame: during the treatment period
during the treatment period
Percentage of subjects who exceed the hemoglobin threshold
Time Frame: throughout study
throughout study
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
Time Frame: throughout study
throughout study
Incidence, if any, of neutralizing antibody formation to darbepoetin alfa
Time Frame: throughout study
throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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