Spots Global Cancer Trial Database for Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

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Trial Identification

Brief Title: Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Official Title: 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

Study ID: NCT00272662

Conditions

Chemotherapy Induced Anemia

Cancer

Interventions

peginesatide

Study Description

Brief 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.