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Completed

NCT Number: NCT00118638

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

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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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-myeloid malignancy
  • At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
  • Of legal age at the time written informed consent is obtained

Exclusion criteria

  • Known history of seizure disorder
  • Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
  • Unstable or uncontrolled disease/condition, related to or affecting cardiac function
  • Clinically significant inflammatory disease
  • Inadequate renal and/or liver function
  • Known positive HIV test
  • Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
  • Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
  • Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
  • Other investigational procedures
  • Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
  • Pregnant or breast feeding
  • Not using adequate contraceptive precautions
  • Known sensitivity to any of the products to be administered during dosing
  • Previously randomized in this study
  • Concerns for subject's compliance with protocol procedures

Treatment and study plan

Darbepoetin alfa - 2.25 mcg/kg

Drug

Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Darbepoetin alfa - 500mcg

Drug

Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Primary outcomes

  1. Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)

    Time frame: from week 5 to EOTP

Secondary outcomes

  1. Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP

    Time frame: from week 5 to EOTP

  2. Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP

    Time frame: from week 1 (day 1) to EOTP

  3. Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP

    Time frame: from week 1 to EOTP

  4. Change in FACT-G Physical Well-being subscale from baseline to EOTP

    Time frame: from baseline to EOTP

  5. Change in hemoglobin from baseline to EOTP

    Time frame: from baseline to EOTP

  6. Change in FACT-Fatigue subscale score from baseline to EOTP

    Time frame: from baseline to EOTP

  7. Change in FACT-G total score from baseline to EOTP

    Time frame: from baseline to EOTP

  8. Change in EQ-5D Thermometer from baseline to EOTP

    Time frame: from baseline to EOTP

  9. Change in BSI Anxiety scale score from baseline to EOTP

    Time frame: from baseline to EOTP

  10. Change in BSI Depression scale score from baseline to EOTP

    Time frame: from baseline to EOTP

  11. Incidence and severity of adverse events

    Time frame: throughout study

  12. Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study

    Time frame: at any time on study

  13. Change in number of caregiver hours from baseline to EOTP

    Time frame: from baseline to EOTP

  14. Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences

    Time frame: throughout study

  15. Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences

    Time frame: throughout study

  16. Incidence of a confirmed antibody formation to darbepoetin alfa

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Important dates

Study start
2004
Primary completion
2004
Study completion
2005
First posted
Jul 12, 2005
Registry last updated
Apr 29, 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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