Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043756
• Other study ID #: cspcmitlip
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2014
• Last updated: January 21, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: January 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 the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Mitoxantrone Hydrochloride Liposome
6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles
• Mitoxantrone
10mg/m2, IV ,on day 1 of each 28 day,3 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome		3 Weeks	Yes