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OpenTrials
Completed

NCT Number: NCT00035607

Chemotherapy Related Anemia

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).

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Non-Myeloid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darbepoetin alfa SC

Drug

Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Darbepoetin alfa IV

Drug

Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period

    Time frame: during the treatment period

  4. Time to and percentage of subjects with a hemoglobin response during the treatment period

    Time frame: during the treatment period

  5. Percentage of subjects who exceed the hemoglobin threshold

    Time frame: throughout study

  6. Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events

    Time frame: throughout study

  7. Incidence, if any, of neutralizing antibody formation to darbepoetin alfa

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2003
First posted
May 6, 2002
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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