Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

Phase 1

• Conditions: Malignant Lymphoma
• Interventions: Drug: Mitoxantrone Hydrochloride Liposome

• Registration Number: NCT02131688
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.

Detailed Description

The trial of the dose escalation method is from 18mg/m2 until the maximum tolerated dose and every 3 patient is a dose group.

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-03
• Study First Submitted: 2014-05-04
• Study First Submitted QC: 2014-05-04
• Last Update Submitted: 2014-05-04
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06
• Primary Completion: 2015-08
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitoxantrone Hydrochloride Liposome	Mitoxantrone Hydrochloride Liposome	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection	4 months

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	4 months

Trial Locations

Locations (1)

Cancer Hospital ,Chinese Academy of Mddical Sciences; 🇨🇳 Beijing, China