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A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

NCT ID: NCT05086822

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-09

Study Completion Date

2017-08-28

Brief Summary

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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

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A dose-escalation（3+3 design） and expansion study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group A

Treatment group : Irinotecan liposome

Group Type EXPERIMENTAL

Irinotecan liposome

Intervention Type DRUG

Irinotecan liposome

Interventions

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Irinotecan liposome

Irinotecan liposome

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YLTKL-Ia-1

Identifier Type: -

Identifier Source: org_study_id