Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

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

Detailed Description
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Mitoxantrone Hydrochloride Liposome
* Drug: Mitoxantrone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoxantrone Hydrochloride Liposome<br>Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart | Drug: Mitoxantrone Hydrochloride Liposome<br>* 6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles<br>* Other names: 2010L04017;|
| Active Comparator: Mitoxantrone ,injection<br>When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator | Drug: Mitoxantrone<br>* 10mg/m2, IV ,on day 1 of each 28 day,3 cycles<br>* Other names: Novantrone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome |  | 3 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitoxantrone Hydrochloride Liposome Injection