The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if needed, and to bridge data from studies previously conducted with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be comparable to those of Process 1 patritumab.
Process 2 patritumab will be administered intravenously as a single, loading dose of 18 mg/kg over approximately 60 minutes at Cycle 1 Day 1 followed by 9 mg/kg administered every 21 days as a maintenance dose starting at Cycle 2 Day 1. This study will be conducted in 2 phases: a main study and an extension phase. The PK profile of Process 2 patritumab will be compared to historical data for Process 1 patritumab. Specifically, the PK parameters (AUC0-21d and Cmax as primary endpoints) for Process 2 patritumab 18 mg/kg (loading dose) will be compared to the PK parameters of Process 1 patritumab 18 mg/kg. Process 2 patritumab serum concentrations will be compared to Process 1 patritumab serum concentrations collected in the Phase 1 and Phase 2 studies by population PK methods and will be reported separately.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
San Antonio, Texas, United States
AUC (0-21 day) of Patritumab
AUC (0-21 day) of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)
Time frame: 5 Cycles, each of which lasts 21 Days
Cmax of Patritumab
Cmax of patritumab obtained after a single infusion of Process 2 patritumab 18 mg/kg (loading dose)
Time frame: 5 Cycles, each of which lasts 21 Days
volume of distribution [Vz]
To assess the secondary PK parameters volume of distribution \[Vz\]
Time frame: 5 Cycles, each of which lasts 21 Days
Safety and Tolerability of Process 2 patritumab - (electrocardiograms [ECG)
To assess the safety and tolerability of Process 2 patritumab (electrocardiograms \[ECG)
Time frame: 5 Cycles, each of which lasts 21 Days
Antibody Formation
To characterize the formation of antibodies to patritumab human antihuman antibodies (HAHA) after infusion of Process 2 patritumab
Time frame: 5 Cycles, each of which lasts 21 Days
Concentration patritumab at 504 hours
To assess the secondary PK parameter concentration of patritumab at 504h \[C504\]
Time frame: 5 Cycles, each of which lasts 21 Days
AUC to infinity [AUC0-inf]
To assess the secondary PK parameters AUC to infinity \[AUC0-inf\]
Time frame: 5 Cycles, each of which lasts 21 Days
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time to Cmax (Tmax)
To assess the secondary PK parameters time to Cmax (Tmax)
Time frame: 5 Cycles, each of which lasts 21 Days
concentration at the end of infusion (Ceoi)
To assess the secondary PK parameters concentration at the end of infusion (Ceoi)
Time frame: 5 Cycles, each of which lasts 21 Days
terminal elimination half-life (t 1/2)
To assess the secondary PK parameters terminal elimination half-life (t 1/2)
Time frame: 5 Cycles, each of which lasts 21 Days
clearance (CL)
To assess the secondary PK parameters clearance (CL)
Time frame: 5 Cycles, each of which lasts 21 Days
trough concentration (Ctrough)
To assess the secondary PK parameters trough concentration (Ctrough)
Time frame: 5 Cycles, each of which lasts 21 Days
echocardiograms/multi-gated acquisition [MUGA] scans of Process 2 patritumab
To assess the safety and tolerability of Process 2 patritumab echocardiograms/multi-gated acquisition \[MUGA\] scans
Time frame: 5 Cycles, each of which lasts 21 Days
adverse events [AEs] of Process 2 patritumab
To assess the safety and tolerability of Process 2 patritumab adverse events \[AEs\] of Process 2 patritumab
Time frame: 5 Cycles, each of which lasts 21 Days