NCT00540696

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anemia
• Non-Myeloid Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-09-01
• Primary completion: 2003-06-01
• Completion: 2003-09-01
• First posted: 2007-10-08
• Last updated: 2013-04-26