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

Advanced Pancreatic Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482257
• Other study ID #: HE072-BE-002
• Status: Recruiting
• Phase: Phase 1
• Start date: July 7, 2020
• Est. completion date: March 2021

Study information

• Verified date: July 2020
• Source: CSPC Ouyi Pharmaceutical Co., Ltd.
• Contact: xuekun Yao
• Phone: 0311-67808678
• Email: yaoxuekun[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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;

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).	0 -190 hours
Primary	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
Primary	AUC0-8	The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (8) will be calculated for the test product (CSPC) or the reference product (Ipsen).	0 -190 hours
Primary	Tmax	The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).	0 -190 hours
Primary	t1/2	The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).	0 -190 hours
Primary	?z	The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).	0 -190 hours