Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

NCT ID: NCT02131688

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Malignant Lymphoma

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone Hydrochloride Liposome

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome

Intervention Type: DRUG

Interventions

Mitoxantrone Hydrochloride Liposome

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital ,Chinese Academy of Mddical Sciences

Locations

Cancer Hospital ,Chinese Academy of Mddical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuankai Shi, Ph.D

Role: primary

010-87788701

Other Identifiers

CSPC-HE14Ⅰ

Identifier Type: -

Identifier Source: org_study_id