Advanced Pancreatic CancerPhase 1NCT04482257
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
A Phase 1 study testing Irinotecan Liposome Injection combined with 5-FU/LV in people with Advanced Pancreatic Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Irinotecan Liposome Injection combined with 5-FU/LV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2020to Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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；
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- 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;
- Patients who are not suitable for this study as determined by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Tianqiang Song, 022-23340123 ext. 6012, ec_tjcih@126.com
About this study
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.
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
Read the 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Irinotecan Liposome Injection combined with 5-FU/LV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Liposome Injection combined with 5-FU/LVDrug
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;
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Irinotecan Liposome Injection combined with 5-FU/LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).
Measured: 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).
Measured: 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).
Measured: 0 -190 hours
Tmax
The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).
Measured: 0 -190 hours
t1/2
The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).
Measured: 0 -190 hours
λz
The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).
Measured: 0 -190 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start7 Jul 2020
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, Ph.D, Principal investigator, Tianjin Cancer Hospital Airport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482257
- Sponsor's protocol ID
- HE072-BE-002
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04482257
- Acronym / sponsor ID
- HE072-BE-002
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-R | Experimental | Drug: Irinotecan Liposome Injection combined with 5-FU/LVSubjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV |
| R-T | Experimental | Drug: Irinotecan Liposome Injection combined with 5-FU/LVSubjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan Liposome Injection combined with 5-FU/LVDrug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV; | Drug | R-T, T-R |
Primary outcome
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).
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).
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).
Tmax
Time frame: 0 -190 hours
The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).
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).
λz
Time frame: 0 -190 hours
The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihui Hao, Ph.D principal investigator
Tianjin Cancer Hospital Airport Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irinotecan Liposome Injection combined with 5-FU/LV in people with Advanced Pancreatic Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuekun Yao (0311-67808678, yaoxuekun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0 -190 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.