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NCT Number: NCT05086848

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
  • Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
  • ECOG: 0-1;
  • Adequate organ and bone marrow function;
  • sign an informed consent.

Exclusion criteria

  • Patients with brain malignant tumor or active CNS metastasis;
  • UGT1A1*28 homozygous mutants;
  • Clinically significant GI disorders;
  • Significant cardiovascular disease;
  • Active infection or uncontrolled fever;
  • Pregnant or breast feeding patients;
  • Allergic to a drug ingredient or component;
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Treatment and study plan

Irinotecan liposome、5-Fluorouracil、Leucovorin

Drug

Irinotecan liposome、5-fluorouracil、Leucovorin

Primary outcomes

  1. Adverse Event (AE)

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

    Assessed by CTCAE v4.03

  2. Dose Limiting Toxicities (DLT)

    Time frame: DLTs will be evaluated during 28-day period following the first dose of study treatment

    Dose Limiting Toxicities for patients in combination treatment

  3. Maximal tolerated dose (MTD)

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

    Maximum tolerated dose for patients in combination treatment

Secondary outcomes

  1. Objective Response Rate

    Time frame: maximum time on study 12 months

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

  2. Progression Free Survival

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

    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.

  3. Time to reach maximum plasma concentration (Tmax)

    Time frame: up to 168 hours after the first dose

    Tmax of total irinotecan, free irinotecan and SN-38

  4. Maximum observed plasma concentration (Cmax)

    Time frame: up to 168 hours after the first dose

    Cmax of total irinotecan, free irinotecan and SN-38

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

    Time frame: up to 168 hours after the first dose

    AUC0-t of total irinotecan, free irinotecan and SN-38

  6. Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)

    Time frame: up to 168 hours after the first dose

    AUC0-inf of total irinotecan, free irinotecan and SN-38

  7. Elimination half-life (T1/2)

    Time frame: up to 168 hours after the first dose

    T1/2 of total irinotecan, free irinotecan and SN-38

  8. Clearance of drug from plasma (CL)

    Time frame: up to 168 hours after the first dose

    CL of total irinotecan

  9. Volume of distribution (Vss)

    Time frame: up to 168 hours after the first dose

    Vss of total irinotecan

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase Ib Study to Evaluate Tolerability, Safety and Pharmacokinetics of Irinotecan Hydrochloride Liposome Injection in Combination With 5-FU/LV in Patients With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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