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

July 21, 2020 updated by: CSPC Ouyi Pharmaceutical Co., Ltd.

*Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
0 -190 hours
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).
0 -190 hours
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).
0 -190 hours
Tmax
Time Frame: 0 -190 hours
The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).
0 -190 hours
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).
0 -190 hours
λz
Time Frame: 0 -190 hours
The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).
0 -190 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jihui Hao, Ph.D, Tianjin Cancer Hospital

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HE072-BE-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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