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Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02131688
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
29
Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mitoxantrone Hydrochloride Liposome
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2015
Anticipated Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mitoxantrone Hydrochloride Liposome

Drug: Mitoxantrone Hydrochloride Liposome

Outcome Measures

Primary Outcome Measures

  1. Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection [4 months]

Secondary Outcome Measures

  1. Objective Response Rate [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital ,Chinese Academy of Mddical Sciences Beijing China

Sponsors and Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Yuankai Shi, Ph.D, Cancer Hospital ,Chinese Academy of Mddical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02131688
Other Study ID Numbers:
  • CSPC-HE14Ⅰ
First Posted:
May 6, 2014
Last Update Posted:
May 6, 2014
Last Verified:
Mar 1, 2014
Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
safety;malignant lymphoma;
Additional relevant MeSH terms:
Lymphoma
Mitoxantrone

Study Results

No Results Posted as of May 6, 2014