Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

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

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Mitoxantrone

Criteria

Inclusion criteria:

• Patients must compliance with the requirements and restrictions listed in the consent form

• Patients with Pathology and / or cytologically proven malignant solid tumor

• Patients must be 18-70 years old ,both male and female

• Failure of standard chemotherapy

• Patients have no better choice and may be benefit from the use of anthracyclines

• Patients must have Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2

• Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks

• Expected survival time ≥ 3 months

• Patients agreed to take effective contraceptive measures during the trial

• Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.

Exclusion criteria:

• Pregnancy and breast-feeding women

• Multiple sclerosis

• Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease

• Patients with heart disease induced by anthracycline

• Patients requiring other antineoplastic treatment

• Patients with temperature above 38 degrees or active infection that may effects in clinical tests

• Patients are allergic to anthracycline and liposomal drugs

• Patients are allergic to eggs,egg products,soybean and soybean products

• Patients with uncontrolled primary or metastatic brain tumors