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Study Complete
Sponsor ID
20030231

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

Sponsor ID
20030231
Clinicaltrials.gov ID
NCT00118638
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
705
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: from week 5 to EOTP

Secondary Outcome Measures

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

Timeframe: from week 5 to EOTP

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

Timeframe: from week 1 (day 1) to EOTP

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

Timeframe: from week 1 to EOTP

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

Timeframe: from baseline to EOTP

Change in hemoglobin from baseline to EOTP

Timeframe: from baseline to EOTP

Change in FACT-Fatigue subscale score from baseline to EOTP

Timeframe: from baseline to EOTP

Change in FACT-G total score from baseline to EOTP

Timeframe: from baseline to EOTP

Change in EQ-5D Thermometer from baseline to EOTP

Timeframe: from baseline to EOTP

Change in BSI Anxiety scale score from baseline to EOTP

Timeframe: from baseline to EOTP

Change in BSI Depression scale score from baseline to EOTP

Timeframe: from baseline to EOTP

Incidence and severity of adverse events

Timeframe: throughout study

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

Timeframe: at any time on study

Change in number of caregiver hours from baseline to EOTP

Timeframe: from baseline to EOTP

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

Timeframe: throughout study

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

Timeframe: throughout study

Incidence of a confirmed antibody formation to darbepoetin alfa

Timeframe: throughout study

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
    • Show more
  • Anemia of Cancer
    • Sex
    All
    Trial Dates
    Mar 2004 - Dec 2004
    Inclusion and Exclusion Criteria
    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