Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness 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 lymphoma

• 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 with 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 tumorsMultiple 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

• Total amount of Doxorubicin(or Pirarubicin)≥360mg/m2,Epirubicin ≥600mg/m2