Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

January 21, 2014 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mitoxantrone Hydrochloride Liposome
Dose escalation will begin at 6mg/m2 to 16mg/m2,4 weeks apart
Drug: Mitoxantrone Hydrochloride Liposome
6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles
Other Names:
  • 2010L04017
ACTIVE_COMPARATOR: Mitoxantrone ,injection
When the dose of experiment drup up 10mg/m2,10mg/m2 of Mitoxantrone as active comparator
Drug: Mitoxantrone
10mg/m2, IV ,on day 1 of each 28 day,3 cycles
Other Names:
  • Novantrone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Yuankai Shi, Ph.D, Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701
  • Study Director: Jianliang Yang, Ph.D, Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788121
  • Study Director: Xiaohong Han, Ph.D, Cancer Hospital ,Chinese Academy of Mddical Sciences 010-87788701

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cspcmitlip

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on Mitoxantrone Hydrochloride Liposome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe