Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin alfa
Study Details
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.
Protocol Summary
Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score
Timeframe: baseline
Relationship between hemoglobin (hgb) response and change in functional capacity
Timeframe: week 1, week 9, week 17
Estimates of the sensitivity and specificity of the FCST
Timeframe: N/A
Relationship between hgb variables and changes on the MHST score, the FCST and its components
Timeframe: 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
Timeframe: 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)
Timeframe: from baseline to any point during the study
Hgb improvement (defined as correction and/or response)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: throughout the study
Safety of darbepoetin alfa as determined by antibody formation
Timeframe: throughout the study
Changes in concomitant medications
Timeframe: 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)
Timeframe: 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)
Timeframe: at any point during the study