Clinical trial NCT05086848: A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a dose-escalation and expansion study
Primary purpose: TREATMENT

Brief 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. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
2. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
3. ECOG: 0-1;
4. Adequate organ and bone marrow function;
5. sign an informed consent.

Exclusion Criteria:

1. Patients with brain malignant tumor or active CNS metastasis;
2. UGT1A1\*28 homozygous mutants;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Primary outcomes:
measure: Adverse Event (AE)
timeFrame: Assessed from study inclusion to 30 days after last dose
measure: Dose Limiting Toxicities (DLT)
timeFrame: DLTs will be evaluated during 28-day period following the first dose of study treatment
measure: Maximal tolerated dose (MTD)
timeFrame: after the last patient in each cohort up to 12 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: maximum time on study 12 months
measure: Progression Free Survival
timeFrame: The maximum time in follow up was 12 months
measure: Time to reach maximum plasma concentration (Tmax)
timeFrame: up to 168 hours after the first dose
measure: Maximum observed plasma concentration (Cmax)
timeFrame: up to 168 hours after the first dose
measure: Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)
timeFrame: up to 168 hours after the first dose
measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)
timeFrame: up to 168 hours after the first dose
measure: Elimination half-life (T1/2)
timeFrame: up to 168 hours after the first dose
measure: Clearance of drug from plasma (CL)
timeFrame: up to 168 hours after the first dose
measure: Volume of distribution (Vss)
timeFrame: up to 168 hours after the first dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
References: