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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05086848
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 5, 2016
Status verified
Sep 2021
Primary completion
Jun 6, 2018
Completion
Jun 6, 2018

Study Design

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

Arms

  • Experimental: Treatment group:
    Irinotecan liposome plus 5-fluorouracil, Leucovorin

Primary Outcome Measure

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

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