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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05086848
Other study ID # YLTKL-Ib
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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