A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05086822
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 9, 2014
Status verified
Sep 2021
Primary completion
Aug 28, 2017
Completion
Aug 28, 2017

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
    Treatment group : Irinotecan liposome

Primary Outcome Measure

Adverse Event (AE) [ Time Frame: Assessed from study inclusion to 30 days after last dose ]

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