NCT00272662

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Affymax · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.

Detailed description

This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.

Conditions

• Chemotherapy Induced Anemia
• Cancer

Interventions

Type	Name	Description
DRUG	peginesatide

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-01-09
• Last updated: 2012-12-21

Locations

10 sites across 3 countries: Czechia, Poland, United Kingdom