Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

May 4, 2014 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Cancer Hospital ,Chinese Academy of Mddical Sciences
        • Contact:
          • Yuankai Shi, Ph.D
          • Phone Number: 010-87788701
        • Principal Investigator:
          • Yuankai Shi, Ph.D
        • Sub-Investigator:
          • Jianliang Yang, Ph.D

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 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 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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitoxantrone Hydrochloride Liposome
Drug: Mitoxantrone Hydrochloride Liposome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: 4 months
4 months

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

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

May 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

May 4, 2014

First Submitted That Met QC Criteria

May 4, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-HE14Ⅰ

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.

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