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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Research Facilities
Brno, Czechia
Research Facility
Hradec Králové, Czechia
Research Facility
Olomouc, Czechia
Research Facility
Příbram, Czechia
Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1
Time frame: Week 9 post Dose 1
Incidence of adverse events and serious adverse events
Time frame: 13 Weeks
Time to achieve hemoglobin increase ≥ 1 g/dL from baseline
Time frame: Baseline to Week 13
Proportion of participants with a hemoglobin response
Time frame: 13 Weeks
Pharmacokinetic parameters
Time frame: 13 Weeks
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