Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.

Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID: NCT04482257
Phase: PHASE1
Status: Unknown

Conditions

Advanced Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Irinotecan Liposome Injection combined with 5-FU/LV — DRUG
Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;

Study Details

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.

Key Dates

Start date: Jul 7, 2020
Status verified: Jul 2020
Primary completion: Dec 31, 2020
Completion: Mar 31, 2021

Study Design

Enrollment: 48 participants (estimated)
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Arms

Experimental: T-R
Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV
Experimental: R-T
Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV

Primary Outcome Measure

Cmax [ Time Frame: 0 -190 hours ]

Central Contacts

xuekun Yao
0311-67808678
[email protected]