A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

Jiangsu HengRui Medicine Co., Ltd.32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

Irinotecan liposomeDRUG

Irinotecan liposome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Adverse Event (AE)

Assessed by CTCAE 4.03

Time frame: Assessed from study inclusion to 30 days after last dose

Dose Limiting Toxicities (DLT)

Dose limiting toxicities for patients in the treatment

Time frame: DLTs will be evaluated during 21-day period following the first dose of study treatment

Maximal tolerated dose (MTD)

Maximum tolerated dose for patients in the treatment

Time frame: after the last patient in each cohort up to 12 months

Secondary Outcomes

Objective Response Rate

Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time frame: maximum time on study 12 months

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.

Time frame: The maximum time in follow up was 12 months

Time to reach maximum plasma concentration (Tmax)

Tmax of total irinotecan, free irinotecan and SN-38

Time frame: up to 120 hours after the first dose

Maximum observed plasma concentration (Cmax)

Cmax of total irinotecan, free irinotecan and SN-38

Time frame: up to 120 hours after the first dose

Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)

Data from ClinicalTrials.gov

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