- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596373
A Study of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
August 15, 2018 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Randomized, Open-label, Positive-controlled, Single-institutional, Phase Ⅱ of Mitoxantrone Hydrochloride Liposome Injection in Advanced Recurrent or Metastatic Breast Cancer
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
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xichun Hu, Ph.D
- Phone Number: +8613816110335
- Email: xchu2009@hotmail.com
Study Locations
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Shanghai, China
- Recruiting
- Fudan University Cancer Hospital
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Contact:
- Xichun Hu, Ph.D
- Phone Number: +8613816110335
- Email: xchu2009@hotmail.com
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Principal Investigator:
- Xichun Hu, Ph.D
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ORR(Objective reponse rate)
Time Frame: 4-8 Months
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4-8 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS(Progression free survival)
Time Frame: 2.5 Years
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2.5 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xichun Hu, Ph.D, Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
January 1, 2018
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 4, 2015
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Breast Diseases
- Breast Neoplasms
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Mitoxantrone
Other Study ID Numbers
- CSPC-HE1506/PRO/Ⅰ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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