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

NCT04482257 | Unknown Phase 1

• 1 other identifier: HE072-BE-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Cmax

  Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).

  0 -190 hours

• AUC0-t

  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).

  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

• Tmax

  The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).

  0 -190 hours

• t1/2

  The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).

  0 -190 hours

• λz

  The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).

  0 -190 hours

Study Arms (2)

T-R

EXPERIMENTAL

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

R-T

EXPERIMENTAL

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

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;

R-T; T-R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent for participation in the trial.
• Advanced pancreatic cancer diagnosed by histopathology and / or cytology.
• Age ≥ 18 years, men or women. BMI is above 17.
• ECOG score 0 to 2.
• Life expectancy ≥ 3 months.
• Adequate bone marrow function.
• Adequate hepatic function.
• Adequate renal function.
• Patient with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the trial

You may not qualify if:

• 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 ;
• Patients who have previously used irinotecan liposomes and experienced treatment failure or serious adverse reactions;
• 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;
• Patients who have undergone major surgery within 4 weeks of screening or have a schedule for major surgery during the study period;
• 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;
• 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；
• Blood donation or massive blood loss (\>400mL) within 90 days of screening;
• Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4 weeks of the first dose of the study drug;
• Patients who received certain diet (such as grapefruit) which may interfere with the evaluation of PK results;
• LVEF≤50%;
• Patients with extended QT/QTc interval (QTcF\>480ms);
• History of alcohol or drugs abuse;
• Pregnant or lactating women;
• 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;
• Patients with homozygous UGT1A1\*28 genotype or UGT1A1\*6 genotype;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Officials

• Jihui Hao, Ph.D

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xuekun Yao

CONTACT

0311-67808678; yaoxuekun@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 22, 2020
• Study Start: July 7, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)