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Completed

NCT Number: NCT00110955

Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

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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

  • Subjects with non-myeloid malignancy
  • At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
  • Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
  • Adequate serum folate and vitamin B12
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Of legal age at the time written informed consent is obtained

Exclusion criteria

  • Known history of seizure disorder
  • Known primary hematologic disorder causing anemia other than non-myeloid malignancies
  • Unstable/uncontrolled cardiac condition
  • Clinically significant inflammatory disease
  • Other diagnoses not related to the cancer which can cause anemia
  • Inadequate renal and liver function
  • Iron deficiency
  • Known positive test for HIV infection
  • Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
  • Received more than 2 red blood cell (RBC) transfusions within 4 weeks of 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 of study day 1 or any planned erythropoietic therapy between randomization and study day 1
  • Other investigational procedures
  • Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
  • Pregnant or breast feeding
  • Not using adequate contraceptive precautions
  • Previously randomized into this study
  • Known hypersensitivity to any products to be administered
  • Concerns for subject's compliance

Treatment and study plan

darbepoetin alfa

Drug

Q3W 300 mcg darbepoetin alfa

Placebo

Drug

Q3W dosing of placebo

Primary outcomes

  1. Incidence of red blood cell (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 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. Number of RBC transfusions from week 5 to EOTP

    Time frame: from week 5 to EOTP

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

    Time frame: from baseline to EOTP

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

    Time frame: from baseline to EOTP

  5. Incidence and severity of adverse events

    Time frame: throughout study

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

    Time frame: at any time on study

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

    Time frame: from baseline to EOTP

  8. 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

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

    Time frame: from baseline to EOTP

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

    Time frame: from baseline to EOTP

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

    Time frame: from baseline to EOTP

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

    Time frame: from baseline to EOTP

  13. 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, Placebo-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
2005
Study completion
2005
First posted
May 17, 2005
Registry last updated
Jan 15, 2010

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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