A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Irinotecan liposome

• Registration Number: NCT05086822
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

This is an open label, dose-escalation and expansion, single centre, phase Ia study . In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-09
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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, lymphoma or other malignant hematologic diseases;
2. Active CNS metastasis;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group A	Irinotecan liposome	Treatment group : Irinotecan liposome

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	Assessed from study inclusion to 30 days after last dose	Assessed by CTCAE 4.03
Dose Limiting Toxicities (DLT)	DLTs will be evaluated during 21-day period following the first dose of study treatment	Dose limiting toxicities for patients in the treatment
Maximal tolerated dose (MTD)	after the last patient in each cohort up to 12 months	Maximum tolerated dose for patients in the 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.
Maximum observed plasma concentration (Cmax)	up to 120 hours after the first dose	Cmax 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 120 hours after the first dose	AUC0-inf of total irinotecan, free irinotecan and SN-38
Clearance of drug from plasma (CL)	up to 120 hours after the first dose	CL of total irinotecan
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)
Elimination half-life (T1/2)	up to 120 hours after the first dose	T1/2 of total irinotecan, free irinotecan and SN-38
Volume of distribution (Vss)	up to 120 hours after the first dose	Vss of total irinotecan
Time to reach maximum plasma concentration (Tmax)	up to 120 hours after the first dose	Tmax of total irinotecan, free irinotecan and SN-38
Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)	up to 120 hours after the first dose	AUC0-t of total irinotecan, free irinotecan and SN-38

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China