A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

• Status: Completed
• Trial end date: 2017-08-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

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, 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.