A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT05086848
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group: Irinotecan liposome、5-fluorouracil、Leucovorin Irinotecan liposome plus 5-fluorouracil, Leucovorin
- Primary Outcome Measures
Name Time Method Adverse Event (AE) Assessed from study inclusion to 30 days after last dose Assessed by CTCAE v4.03
Dose Limiting Toxicities (DLT) 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) after the last patient in each cohort up to 12 months Maximum tolerated dose for patients in combination treatment
- Secondary Outcome Measures
Name Time Method Progression Free Survival The maximum time in follow up was 12 months 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.
Time to reach maximum plasma concentration (Tmax) up to 168 hours after the first dose Tmax of total irinotecan, free irinotecan and SN-38
Maximum observed plasma concentration (Cmax) up to 168 hours after the first dose Cmax of total irinotecan, free irinotecan and SN-38
Objective Response Rate maximum time on study 12 months Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t) up to 168 hours after the first dose AUC0-t of total irinotecan, free irinotecan and SN-38
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf) up to 168 hours after the first dose AUC0-inf of total irinotecan, free irinotecan and SN-38
Elimination half-life (T1/2) up to 168 hours after the first dose T1/2 of total irinotecan, free irinotecan and SN-38
Clearance of drug from plasma (CL) up to 168 hours after the first dose CL of total irinotecan
Volume of distribution (Vss) up to 168 hours after the first dose Vss of total irinotecan
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China