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Clinical Trial Record

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

2020-07-07

2020-12

2021-03

48

Study Overview

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

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

The purpose of this study was to determine the bioequivalence of two formulations of Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer, under fasting condition. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

  • Advanced Pancreatic Cancer
  • DRUG: Irinotecan Liposome Injection combined with 5-FU/LV
  • HE072-BE-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-07-20  

N/A  

2020-07-21  

2020-07-21  

N/A  

2020-07-22  

2020-07-22  

N/A  

2020-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
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

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;
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

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;
Primary Outcome MeasuresMeasure DescriptionTime Frame
CmaxCmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
AUC0-tThe exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
AUC0-∞The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
TmaxThe time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
t1/2The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
λzThe terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).0 -190 hours
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: xuekun Yao

Phone Number: 0311-67808678

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Signed written informed consent for participation in the trial. 2. Advanced pancreatic cancer diagnosed by histopathology and / or cytology. 3. Age ≥ 18 years, men or women. BMI is above 17. 4. ECOG score 0 to 2. 5. Life expectancy ≥ 3 months. 6. Adequate bone marrow function. 7. Adequate hepatic function. 8. Adequate renal function. 9. Patient with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the trial
    Exclusion Criteria:
    1. Patients who have a severe allergy or a significant history of hypersensitivity or an idiopathic reaction attributed to irinotecan or compounds of similar chemical composition to irinotecan ; 2. Patients who have previously used irinotecan liposomes and experienced treatment failure or serious adverse reactions; 3. Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric diseases that occurred within 3 months of the first dose of the study drug, and not suitable for this study as determined by the researchers; 4. Patients who have undergone major surgery within 4 weeks of screening or have a schedule for major surgery during the study period; 5. Patients who have received any radiotherapy or chemotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, traditional Chinese medicine with anti-tumor indications within 4 weeks of the first dose of the study drug, or small molecule targeted drugs within 2 weeks (or 5 half-lives whichever is longer) of the first dose of the study drug; 6. Patients who currently enrolled in any other clinical study, or received other investigational agents within 4 weeks of the first dose of the study drug； 7. Blood donation or massive blood loss (>400mL) within 90 days of screening; 8. Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4 weeks of the first dose of the study drug; 9. Patients who received certain diet (such as grapefruit) which may interfere with the evaluation of PK results; 10. LVEF≤50%; 11. Patients with extended QT/QTc interval (QTcF>480ms); 12. History of alcohol or drugs abuse; 13. Pregnant or lactating women; 14. Patients with known Hepatitis B Virus (HBV DNA≥104), Hepatitis C Virus (anti-HCV positive, HCV RNA positive), Human immunodeficiency virus antibody (anti-HIV positive), or active Treponema Pallidum viral infection; 15. Patients with homozygous UGT1A1*28 genotype or UGT1A1*6 genotype; 16. Patients who are not suitable for this study as determined by the researchers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Jihui Hao, Ph.D, Tianjin Cancer Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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