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

• Status: Completed
• Trial end date: 2018-06-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Fluorouracil; Irinotecan; Leucovorin

Criteria

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 or active CNS metastasis;

2. UGT1A1*28 homozygous mutants;

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.