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
Overview
- Phase
- Phase 1
- Intervention
- Irinotecan liposome、5-fluorouracil、Leucovorin
- Conditions
- Advanced Solid Tumors
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Adverse Event (AE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
- •Adequate organ and bone marrow function;
- •sign an informed consent.
Exclusion Criteria
- •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.
Arms & Interventions
Treatment group:
Irinotecan liposome plus 5-fluorouracil, Leucovorin
Intervention: Irinotecan liposome、5-fluorouracil、Leucovorin
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Progression Free Survival(The maximum time in follow up was 12 months)
- Time to reach maximum plasma concentration (Tmax)(up to 168 hours after the first dose)
- Maximum observed plasma concentration (Cmax)(up to 168 hours after the first dose)
- Objective Response Rate(maximum time on study 12 months)
- 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)
- Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)(up to 168 hours after the first dose)
- Elimination half-life (T1/2)(up to 168 hours after the first dose)
- Clearance of drug from plasma (CL)(up to 168 hours after the first dose)
- Volume of distribution (Vss)(up to 168 hours after the first dose)