Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Mitoxantrone; Drug: Mitoxantrone Hydrochloride Liposome

Study type: Interventional

Funder types: Industry

Identifiers

NCT02043756

cspcmitlip

Details and patient eligibility

About

The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Mitoxantrone Hydrochloride Liposome

Experimental group

Description:

Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart

Treatment:

Drug: Mitoxantrone Hydrochloride Liposome

Mitoxantrone ,injection

Active Comparator group

Description:

When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator

Treatment:

Drug: Mitoxantrone