Advanced Solid TumorsPhase 1NCT05086848
A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors
A Phase 1 study testing Irinotecan liposome、5-fluorouracil、Leucovorin in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Irinotecan liposome、5-fluorouracil、Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2016to 6 Jun 2018
- 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
- Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
- Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
- sign an informed consent.
Who cannot join
- Patients with brain malignant tumor or active CNS metastasis;
- UGT1A1*28 homozygous mutants;
- Clinically significant GI disorders;
- Significant cardiovascular disease;
- Active infection or uncontrolled fever;
- Pregnant or breast feeding patients;
- Allergic to a drug ingredient or component;
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase Ib Study to Evaluate Tolerability, Safety and Pharmacokinetics of Irinotecan Hydrochloride Liposome Injection in Combination With 5-FU/LV in Patients With Advanced Solid Tumors
This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
- Conditions
- Advanced Solid Tumors
- Being tested
- Irinotecan liposome、5-fluorouracil、Leucovorin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome、5-fluorouracil、LeucovorinDrug
Irinotecan liposome、5-fluorouracil、Leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: | Experimental | Irinotecan liposome plus 5-fluorouracil, Leucovorin Receives: Drug: Irinotecan liposome、5-fluorouracil、Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Assessed by CTCAE v4.03
Measured: Assessed from study inclusion to 30 days after last dose
Dose Limiting Toxicities (DLT)
Dose Limiting Toxicities for patients in combination treatment
Measured: DLTs will be evaluated during 28-day period following the first dose of study treatment
Maximal tolerated dose (MTD)
Maximum tolerated dose for patients in combination treatment
Measured: after the last patient in each cohort up to 12 months
Secondary outcomes (9)
Objective Response Rate
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: maximum time on study 12 months
Progression Free Survival
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs first.
Measured: The maximum time in follow up was 12 months
Time to reach maximum plasma concentration (Tmax)
Tmax of total irinotecan, free irinotecan and SN-38
Measured: up to 168 hours after the first dose
Maximum observed plasma concentration (Cmax)
Cmax of total irinotecan, free irinotecan and SN-38
Measured: up to 168 hours after the first dose
Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)
AUC0-t of total irinotecan, free irinotecan and SN-38
Measured: up to 168 hours after the first dose
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)
AUC0-inf of total irinotecan, free irinotecan and SN-38
Measured: up to 168 hours after the first dose
Elimination half-life (T1/2)
T1/2 of total irinotecan, free irinotecan and SN-38
Measured: up to 168 hours after the first dose
Clearance of drug from plasma (CL)
CL of total irinotecan
Measured: up to 168 hours after the first dose
Volume of distribution (Vss)
Vss of total irinotecan
Measured: up to 168 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start5 May 2016
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Not applicable
- Intervention model
- Single group
- Model description
- a dose-escalation and expansion study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086848
- Sponsor's protocol ID
- YLTKL-Ib
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ji D, Shen W, Li T, Wang H, Bai J, Cao J, Hu X. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. Invest New Drugs. 2024 Aug;42(4):462-470. doi: 10.1007/s10637-024-01442-2. Epub 2024 Jul 22.
PubMed 39037543
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate Tolerability, Safety and Pharmacokinetics of Irinotecan Hydrochloride Liposome Injection in Combination With 5-FU/LV in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05086848
- Acronym / sponsor ID
- YLTKL-Ib
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 May 2016 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 21 Oct 2021 (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.
This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a dose-escalation and expansion study
| Arm | Type | Receives |
|---|---|---|
| Treatment group: | Experimental | Drug: Irinotecan liposome、5-fluorouracil、LeucovorinIrinotecan liposome plus 5-fluorouracil, Leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
- Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
- sign an informed consent.
Key exclusion criteria (8 listed)
- Patients with brain malignant tumor or active CNS metastasis;
- UGT1A1*28 homozygous mutants;
- Clinically significant GI disorders;
- Significant cardiovascular disease;
- Active infection or uncontrolled fever;
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、5-fluorouracil、LeucovorinIrinotecan liposome、5-fluorouracil、Leucovorin | Drug | Treatment group: |
Primary outcome
Adverse Event (AE)
Time frame: Assessed from study inclusion to 30 days after last dose
Assessed by CTCAE v4.03
Dose Limiting Toxicities (DLT)
Time frame: DLTs will be evaluated during 28-day period following the first dose of study treatment
Dose Limiting Toxicities for patients in combination treatment
Maximal tolerated dose (MTD)
Time frame: after the last patient in each cohort up to 12 months
Maximum tolerated dose for patients in combination treatment
9 secondary outcomes
Objective Response Rate
Time frame: maximum time on study 12 months
Progression Free Survival
Time frame: The maximum time in follow up was 12 months
Time to reach maximum plasma concentration (Tmax)
Time frame: up to 168 hours after the first dose
Maximum observed plasma concentration (Cmax)
Time frame: up to 168 hours after the first dose
Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)
Time frame: up to 168 hours after the first dose
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)
Time frame: up to 168 hours after the first dose
Elimination half-life (T1/2)
Time frame: up to 168 hours after the first dose
Clearance of drug from plasma (CL)
Time frame: up to 168 hours after the first dose
Volume of distribution (Vss)
Time frame: up to 168 hours after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 39037543Ji D, Shen W, Li T, Wang H, Bai J, Cao J, Hu X. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. Invest New Drugs. 2024 Aug;42(4):462-470. doi: 10.1007/s10637-024-01442-2. Epub 2024 Jul 22.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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、5-fluorouracil、Leucovorin in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) (time frame: Assessed from study inclusion to 30 days after last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086848, which also lists 1 linked publication.
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 21 Oct 2021.