Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor

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

The trial of the dose escalation method is from the minimum dose until the maximum tolerated dose and every 3 patient is a dose group.

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