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1. Maximum (peak) plasma drug concentration (Cmax) of encapsulated irinotecan for Test relative to and Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
2. Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t) of encapsulated irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
3. Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞) of encapsulated irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
Secondary outcome:
1. Maximum (peak) plasma drug concentration (Cmax) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
2. Area under the plasma concentration-time curve from time 0 to time t (AUC(0-t)) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
3. Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)) of total irinotecan for Test relative to Reference product (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
4. Time to maximum plasma concentration (Tmax) of encapsulated and total irinotecan over 15-days for each Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
5. Apparent clearance of drug from plasma (CL) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
6. Apparent volume of distribution (VZ) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
7. Terminal half-life (t1/2) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
8. Apparent terminal elimination rate constant (λZ) of encapsulated and total irinotecan for Test and Reference products (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose)))
9. Percentage of participants with treatment-emergent adverse events (TEAEs) treatment-related leading to discontinuations, or to death (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))): Including treatment-emergent serious adverse events
10. Percentage of participants with clinically significant abnormal values (Time Frame - Crossover Phase (From Cycle 1 Day 1 to Day 28 and Cycle 1 Day 29 (pre-dose))): It includes clinically significant abnormal laboratory results, physical examination findings, Electrocardiogram (ECG) and vital signs
Experimental: Sequence RT: Reference Product followed by Test Product Cycle 1 (Crossover Phase) Day 1: One dose Onivyde® Reference product + 5-FU/LV.
Cycle 1 (Crossover Phase) Day 15: One dose Onivyde Test product + 5-FU/LV
Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV
Experimental: Sequence TR: Test Product followed by Reference Product Cycle 1 (Crossover Phase) Day 1: One dose Onivyde Test product + 5-FU/LV.
Cycle 1 (Crossover Phase) Day 15: One dose Onivyde® Reference product + 5-FU/LV.
Cycle 2 Onwards (Extension Phase): Participants who choose to continue treatment after Cycle 1 will receive Onivyde® Reference product on Day 1 and Day 15 of every 28-day cycle in combination with 5-FU/LV.
Irinotecan liposome injection (Onivyde® Reference product): Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Irinotecan liposome injection (Onivyde Test product): Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase)
Irinotecan liposome injection (Onivyde Test product): Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase)
Irinotecan liposome injection (Onivyde® Reference product): Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Folinic Acid (Leucovorin (LV)): LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle
5-Fluorouracil (5-FU): 5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas"
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