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

NCT04482257 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-07-22

No results posted yet for this study

Summary

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

Conditions

  • Advanced Pancreatic Cancer

Interventions

DRUG

Irinotecan Liposome Injection combined with 5-FU/LV

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;

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jihui Hao, Ph.D · Tianjin Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482257 on ClinicalTrials.gov