Chemotherapy Related Anemia

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Anemia, Non-Myeloid Malignancies

Intervention / Treatment
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* Drug: Darbepoetin alfa SC
* Drug: Darbepoetin alfa IV


Participation Criteria
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Eligibility Criteria
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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

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Darbepoetin alfa SC<br> | Drug: Darbepoetin alfa SC<br>* Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W<br>|
| Experimental: Darbepoetin alfa IV<br> | Drug: Darbepoetin alfa IV<br>* Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) |  | from baseline to the end of treatment period (EOTP) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | throughout study | 
| Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP |  | from baseline to week 7 and from week 7 to EOTP | 
| Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period |  | during the treatment period | 
| Time to and percentage of subjects with a hemoglobin response during the treatment period |  | during the treatment period | 
| Percentage of subjects who exceed the hemoglobin threshold |  | throughout study | 
| Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events |  | throughout study | 
| Incidence, if any, of neutralizing antibody formation to darbepoetin alfa |  | throughout study |