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Trial record 4 of 9 for:    Mitoxantrone HCL Liposome Injection

A Study of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02596373
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or metastatic breast cancer

Condition or disease Intervention/treatment Phase
Advanced Recurrent or Metastatic Breast Cancer Drug: Mitoxantrone Hydrochloride Liposome Injection Phase 2

Detailed Description:
Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator's phase Ⅰstudy has shown that the drug's toxicity is manageable and the tolerable does is 20 mg/m2. The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or metastatic breast cancer. The safety of Mitoxantrone Hydrochloride Liposome Injection will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection is safe and effective in advanced recurrent or metastatic breast cancer patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
Study Start Date : June 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection
Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 4 weeks
Drug: Mitoxantrone Hydrochloride Liposome Injection
Active Comparator: Mitoxantrone Hydrochloride Injection
Mitoxantrone Hydrochloride Injection 14 mg/m2 will be infused intravenously once over 30 minutes in 150 ml 5% glucose injection on the first day during a treatment phase of 4 weeks
Drug: Mitoxantrone Hydrochloride Liposome Injection



Primary Outcome Measures :
  1. ORR(Objective reponse rate) [ Time Frame: 4-8 Months ]

Secondary Outcome Measures :
  1. PFS(Progression free survival) [ Time Frame: 2.5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to study specific screening procedures;
  • ≥ 18 and ≤ 75 years of age,female;
  • Advanced recurrent or Metastatic breast cancer, comfirmed by histological analysis and/or cytology analysis. Have failed for at least two chemotherapy regimen aimed to the advanced recurrent or metastatic focus;
  • Adapted to receive chemotherapy;
  • Women diagnosed with human epidermal growth factor receptor negative(HER2-); Women diagnosed with HER2+, and unable to be treated by Anti-HER2+ targeted therapy. HER2- is defined as 0 or 1+ staining on immunohistochemistry or FISH negative for gene amplification. HER2+ is defined as +++ staining on immunohistochemistry or FISH positive for gene amplification;
  • Not suitable for endocrine theapy or tolerance to endocrine therapy;
  • Have at least one measurable site of disease according to RECIST1.1 criteria;
  • If chemotherapy regimens containing anthracycline-based drugs, duration from palindromia to this chemotherapy regimens is not less than 12 mounths;
  • ECOG performance status of 0-2, life expectancy of more than 3 mounths;
  • Cardiac function is almost normal(NYHA classification is Grade 1, LVEF≥ 50%);
  • Sexually active women of childbearing potential must use a medically acceptable form of contraception;
  • Adequate hepatic, renal and hematologic functions: leukocyte≥3.0×10^9/L,neutrophils≥1.5×10^9/L,platelets≥75×10^9/L, hemoglobin≥90g/L, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), creatinine clearance rate≤1.5×ULN;

Exclusion Criteria:

  • Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer;
  • Uncontrolled brain metastases;
  • Pregnant or lactating women;
  • Mitoxantrone has been used before;
  • Anthracycline-based drugs was used after relapse and metastasis;
  • The cumulative doses of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
  • Less than 4 weeks from the last chemotherapy, less than 4 weeks from the last radiotherapy, less than 2 weeks from the last endocrinotherapy; Other antineoplastic drugs need to be used in this study;
  • History of anthracycline-based drug allergy;
  • History of liposome drug allergy;
  • Uncontrolled psychosis or uncontrolled infections disease;
  • Unsuited to participate in thsi study judged by investigators;

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): NCT02596373


Contacts
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Contact: Xichun Hu, Ph.D +8613816110335 xchu2009@hotmail.com

Locations
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China
Fudan University Cancer Hospital Recruiting
Shanghai, China
Contact: Xichun Hu, Ph.D    +8613816110335    xchu2009@hotmail.com   
Principal Investigator: Xichun Hu, Ph.D         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Xichun Hu, Ph.D Fudan University

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02596373     History of Changes
Other Study ID Numbers: CSPC-HE1506/PRO/Ⅰ
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Mitoxantrone
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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