Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa
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|ClinicalTrials.gov Identifier: NCT00540696|
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : April 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Non-Myeloid Malignancies||Drug: darbepoetin alfa||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||September 2001|
|Primary Completion Date :||June 2003|
|Study Completion Date :||September 2003|
|Experimental: darbepoetin alfa||
Drug: darbepoetin alfa
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.
- Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score [ Time Frame: baseline ]
- Relationship between hemoglobin (hgb) response and change in functional capacity [ Time Frame: week 1, week 9, week 17 ]
- Estimates of the sensitivity and specificity of the FCST
- Relationship between hgb variables and changes on the MHST score, the FCST and its components [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: from baseline to any point during the study ]
- Hgb improvement (defined as correction and/or response) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: throughout the study ]
- Safety of darbepoetin alfa as determined by antibody formation [ Time Frame: throughout the study ]
- Changes in concomitant medications [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: at any point during the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540696