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

Study Overview
=================
Brief Summary
-----------------
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.

Official 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

Conditions
-----------------
Anemia, Non-Myeloid Malignancies

Intervention / Treatment
-----------------
* Drug: Darbepoetin alfa
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darbepoetin alfa - Group A<br> | Drug: Darbepoetin alfa<br>* Q3W 300 mcg darbepoetin alfa<br>|
| Placebo Comparator: Placebo- Group B<br> | Drug: Placebo<br>* Q3W dosing of placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of red blood cell (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 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP |  | from week 5 to EOTP | 
| Number of RBC transfusions from week 5 to EOTP |  | from week 5 to EOTP | 
| Change in FACT-Fatigue subscale score from baseline to EOTP |  | from baseline to EOTP | 
| Change in FACT-G Physical Well-being subscale 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 FACT-G total score 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 | 
| 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 | 
| Change in number of caregiver hours from baseline to EOTP |  | from baseline to EOTP | 
| Incidence of a confirmed antibody formation to darbepoetin alfa |  | throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-myeloid malignancy, Chemotherapy-induced anemia