A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086848
• Other study ID #: YLTKL-Ib
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2016
• Est. completion date: June 6, 2018

Study information

• Verified date: September 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Irinotecan liposome?5-fluorouracil?Leucovorin
Irinotecan liposome?5-fluorouracil?Leucovorin

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event (AE)	Assessed by CTCAE v4.03	Assessed from study inclusion to 30 days after last dose
Primary	Dose Limiting Toxicities (DLT)	Dose Limiting Toxicities for patients in combination treatment	DLTs will be evaluated during 28-day period following the first dose of study treatment
Primary	Maximal tolerated dose (MTD)	Maximum tolerated dose for patients in combination treatment	after the last patient in each cohort up to 12 months
Secondary	Objective Response Rate	Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	maximum time on study 12 months
Secondary	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.	The maximum time in follow up was 12 months
Secondary	Time to reach maximum plasma concentration (Tmax)	Tmax of total irinotecan, free irinotecan and SN-38	up to 168 hours after the first dose
Secondary	Maximum observed plasma concentration (Cmax)	Cmax of total irinotecan, free irinotecan and SN-38	up to 168 hours after the first dose
Secondary	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	up to 168 hours after the first dose
Secondary	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	up to 168 hours after the first dose
Secondary	Elimination half-life (T1/2)	T1/2 of total irinotecan, free irinotecan and SN-38	up to 168 hours after the first dose
Secondary	Clearance of drug from plasma (CL)	CL of total irinotecan	up to 168 hours after the first dose
Secondary	Volume of distribution (Vss)	Vss of total irinotecan	up to 168 hours after the first dose