Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

Study Overview
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Brief Summary
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The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy. Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.

Official Title
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An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)

Conditions
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Anemia, Non-Myeloid Malignancies

Intervention / Treatment
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* Drug: darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-myeloid malignancies Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy Plan to receive cyclic chemotherapy for an additional 8 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Adequate renal and liver function Ability to participate in the MHST based on clinical judgement of investigator At least 18 years of age Exclusion Criteria: Iron deficiency Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment Unstable cardiac disease Current active condition creating clinical danger for the subject to participate in the MHST known positive test for HIV infection Previous hematologic disorder associated with anemia Currently receiving beta-blockers Use of drugs or devices not approved by the FDA for any indication Pregnant or breast feeding Known hypersensitivity to any recombinant mammalian-derived product

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: darbepoetin alfa<br> | Drug: darbepoetin alfa<br>* Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses. Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score |  | baseline | 
| Relationship between hemoglobin (hgb) response and change in functional capacity |  | week 1, week 9, week 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimates of the sensitivity and specificity of the FCST |  |  | 
| Relationship between hgb variables and changes on the MHST score, the FCST and its components |  | from baseline to end of treatment phase | 
| Maximum change in hgb from baseline to any point during the study, excluding hgb measurements obtained within 28 days of a red blood cell (RBC) transfusion |  | from baseline to any point during the study | 
| Number and proportion of subjects who achieve a hgb response as defined by an increase of greater than or equal to 2.0 g/dL from the baseline hgb in absence of any RBC transfusion within the prior 28 days at any point during the study (hgb response) |  | from baseline to any point during the study | 
| Hgb improvement (defined as correction and/or response) |  | from baseline to any point during the study | 
| Change in hgb from baseline to week 17, or the subject's last hgb value excluding hgb measurements obtained within 28 days of a RBC transfusion |  | from baseline to week 17 | 
| Number and proportion of subjects who receive any RBC transfusions, the number of units of RBC transfused, and the number of days with at least 1 RBC transfusion from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase |  | from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase | 
| Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events |  | throughout the study | 
| Safety of darbepoetin alfa as determined by antibody formation |  | throughout the study | 
| Changes in concomitant medications |  | throughout the study | 
| Rapid rise in hgb (a greater than or equal to 2.0 g/dL increase in hgb concentration within a 28-day window during the treatment period) |  | within a 28-day window during the treatment period | 
| Proportion of subjects who achieve a hgb of greater than or equal to 12.0 g/dL at any point during the study (hgb correction) |  | at any point during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Non-Myeloid Malignancies, darbepoetin alfa, chemotherapy