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Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

Primary Purpose

Malignant Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mitoxantrone Hydrochloride Liposome
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Lymphoma focused on measuring safety;malignant lymphoma;

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Cancer Hospital ,Chinese Academy of Mddical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitoxantrone Hydrochloride Liposome

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection

Secondary Outcome Measures

Objective Response Rate

Full Information

First Posted
May 4, 2014
Last Updated
May 4, 2014
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02131688
Brief Title
Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
Official Title
Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Lymphoma
Keywords
safety;malignant lymphoma;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mitoxantrone Hydrochloride Liposome
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone Hydrochloride Liposome
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
Organizational Affiliation
Cancer Hospital ,Chinese Academy of Mddical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital ,Chinese Academy of Mddical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
Phone
010-87788701
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
First Name & Middle Initial & Last Name & Degree
Jianliang Yang, Ph.D

12. IPD Sharing Statement

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Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

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