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

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ClinicalTrials.gov Identifier: NCT04482257
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
CSPC Ouyi Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Drug: Irinotecan Liposome Injection combined with 5-FU/LV Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: *Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/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 Measures :
  1. Cmax [ Time Frame: 0 -190 hours ]
    Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).

  2. AUC0-t [ Time Frame: 0 -190 hours ]
    The 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).

  3. AUC0-∞ [ Time Frame: 0 -190 hours ]
    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).

  4. Tmax [ Time Frame: 0 -190 hours ]
    The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).

  5. t1/2 [ Time Frame: 0 -190 hours ]
    The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).

  6. λz [ Time Frame: 0 -190 hours ]
    The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482257


Contacts
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Contact: xuekun Yao 0311-67808678 yaoxuekun@mail.ecspc.com

Locations
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China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Tianqiang Song    022-23340123 ext 6012    ec_tjcih@126.com   
Sponsors and Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Jihui Hao, Ph.D Tianjin Cancer Hospital
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Responsible Party: CSPC Ouyi Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04482257    
Other Study ID Numbers: HE072-BE-002
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents