Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

Malignant Lymphoma Clinical Trial

Official title:

Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131688
• Other study ID #: CSPC-HE14?
• Status: Recruiting
• Phase: Phase 1
• First received: May 4, 2014
• Last updated: May 4, 2014
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2014
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Malignant Lymphoma

Intervention

Drug:
• Mitoxantrone Hydrochloride Liposome

Locations

Country	Name	City	State
China	Cancer Hospital ,Chinese Academy of Mddical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection		4 months	Yes
Secondary	Objective Response Rate		4 months	No