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Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection

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ClinicalTrials.gov Identifier: NCT02043756
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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
Neoplasms Drug: Mitoxantrone Hydrochloride Liposome Drug: Mitoxantrone 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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Novantrone




Primary Outcome Measures :
  1. To determination the maximal tolerance dose and dose-limiting toxicity of Mitoxantrone Hydrochloride Liposome [ Time Frame: 3 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043756


Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02043756     History of Changes
Other Study ID Numbers: cspcmitlip
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
Mitoxantrone Hydrochloride Liposome Injection

Additional relevant MeSH terms:
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Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action