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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anemia, Non-Myeloid Malignancies

Intervention / Treatment
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* Drug: Darbepoetin alfa - 2.25 mcg/kg
* Drug: Darbepoetin alfa - 500mcg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darbepoetin alfa 500 mcg - Group A<br> | Drug: Darbepoetin alfa - 500mcg<br>* Darbepoetin alfa 500mcg Q3W dosing / placebo QW<br>|
| Active Comparator: Darbepoetin alfa 2.25 mcg/kg - Group B<br> | Drug: Darbepoetin alfa - 2.25 mcg/kg<br>* Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) |  | from week 5 to EOTP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | from week 5 to EOTP | 
| Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP |  | 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 |  | from week 1 to EOTP | 
| Change in FACT-G Physical Well-being subscale from baseline to EOTP |  | from baseline to EOTP | 
| Change in hemoglobin from baseline to EOTP |  | from baseline to EOTP | 
| Change in FACT-Fatigue subscale score from baseline to EOTP |  | from baseline to EOTP | 
| Change in FACT-G total score from baseline to EOTP |  | from baseline to EOTP | 
| Change in EQ-5D Thermometer from baseline to EOTP |  | from baseline to EOTP | 
| Change in BSI Anxiety scale score from baseline to EOTP |  | from baseline to EOTP | 
| Change in BSI Depression scale score from baseline to EOTP |  | from baseline to EOTP | 
| Incidence and severity of adverse events |  | throughout study | 
| Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study |  | at any time on study | 
| Change in number of caregiver hours from baseline to EOTP |  | 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 |  | 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 |  | throughout study | 
| Incidence of a confirmed antibody formation to darbepoetin alfa |  | throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-myeloid malignancy, Darbepoetin alfa, Clinical Trial