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Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02043756
Collaborator
(none)
20
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Solid Tumor
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome [3 Weeks]

    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 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02043756
    Other Study ID Numbers:
    • cspcmitlip
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Jan 23, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Mitoxantrone Hydrochloride Liposome Injection
    Additional relevant MeSH terms:
    Mitoxantrone

    Study Results

    No Results Posted as of Jan 23, 2014