A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
Primary Purpose
Advanced Gastric Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mitoxantrone Hydrochloride Liposome, intravenous injection
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, without gender limitation;
- Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;
- Suitable to receive the study drug as decided by the investigator;
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 to 2;
- Life expectancy ≥ 12 weeks;
- AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);
- Adequate organ function;
- Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
- Fully comply with the protocol.
Exclusion Criteria:
- History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- Amenable to curative surgery ( radical excision);
- Pleural effusion, pericardial effusion or peritoneal effusion with overt clinical symptoms (except for those have a drainage within 1 month before screening, asymptomatic and the effusion only detectable by imageological examination);
- Intestinal obstruction with overt clinical symptom and requiring treatment;
- CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;
- History of allotransplantation;
- Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
- Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
- Use of other anticancer treatment within 4 weeks prior to the first dose administration;
- Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration;
- Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
- Thrombosis or thromboembolism within 6 months prior to screening;
- History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
- Impaired cardiac function or serious cardiac disease;
- Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2.
- Pregnant or lactating female;
- Serious and/or uncontrolled systemic diseases;
Sites / Locations
- Beijing Luhe Hospital Capital Medical UniversityRecruiting
- Fujian Cancer HospitalRecruiting
- Lanzhou University Second HospitalRecruiting
- Hebei General Hospital
- The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital
- Henan Cancer HospitalRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Cancer Hospital of The University of Chinese Academy of ScienceRecruiting
- Taizhou Hospital of Zhejiang Province
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mitoxantrone Hydrochloride Liposome Injection
Arm Description
Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.
Outcomes
Primary Outcome Measures
adverse events (AEs)
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
Secondary Outcome Measures
overall response rate (ORR)
To investigate the preliminary antitumor efficacy
duration of response (DoR)
To investigate the preliminary antitumor efficacy
duration of complete response (DCR)
To investigate the preliminary antitumor efficacy
progression-free survival (PFS)
To investigate the preliminary antitumor efficacy
overall survival (OS)
To investigate the preliminary antitumor efficacy
Full Information
NCT ID
NCT04718402
First Posted
December 14, 2020
Last Updated
May 31, 2021
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04718402
Brief Title
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
Official Title
A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
January 19, 2022 (Anticipated)
Study Completion Date
January 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma.
Detailed Description
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitoxantrone Hydrochloride Liposome Injection
Arm Type
Experimental
Arm Description
Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone Hydrochloride Liposome, intravenous injection
Intervention Description
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Primary Outcome Measure Information:
Title
adverse events (AEs)
Description
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
Time Frame
From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months
Secondary Outcome Measure Information:
Title
overall response rate (ORR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Title
duration of response (DoR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Title
duration of complete response (DCR)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Title
progression-free survival (PFS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Title
overall survival (OS)
Description
To investigate the preliminary antitumor efficacy
Time Frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects fully understand and voluntarily participate in this study and sign informed consent;
Age ≥18, without gender limitation;
Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;
Suitable to receive the study drug as decided by the investigator;
At least one measurable lesion according to RECIST v1.1;
ECOG performance status of 0 to 2;
Life expectancy ≥ 12 weeks;
AEs from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as hair loss, hyperpigmentation);
Adequate organ function;
Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;
Fully comply with the protocol.
Exclusion Criteria:
History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
Untreated or symptomatic central nervous system (CNS) metastases;
Amenable to curative surgery ( radical excision);
Pleural effusion, pericardial effusion or peritoneal effusion with overt clinical symptoms (except for those have a drainage within 1 month before screening, asymptomatic and the effusion only detectable by imageological examination);
Intestinal obstruction with overt clinical symptom and requiring treatment;
CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;
History of allotransplantation;
Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
Use of other anticancer treatment within 4 weeks prior to the first dose administration;
Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration;
Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
Thrombosis or thromboembolism within 6 months prior to screening;
History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
Impaired cardiac function or serious cardiac disease;
Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2.
Pregnant or lactating female;
Serious and/or uncontrolled systemic diseases;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
010-63932012
Email
xiaxuefang@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieer Ying, Doctor
Organizational Affiliation
Cancer Hospital of The University of Chinese Academy of Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Luhe Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Yan, Doctor
Phone
13621308215
Email
yd15yt88@163.com
First Name & Middle Initial & Last Name & Degree
Dong Yan, Doctor
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongbo Lin, Bachelor
Phone
13705919382
Email
rongbo_lin@163.com
First Name & Middle Initial & Last Name & Degree
Rongbo Lin, Bachelor
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Chen, MD
Phone
15009467790
Email
chenhaodrs@163.com
First Name & Middle Initial & Last Name & Degree
Hao Chen, MD
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxia Li, MD
Phone
13613110158
Email
lqx73@163.com
First Name & Middle Initial & Last Name & Degree
Qingxia Li, MD
Facility Name
The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050019
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruixing Zhang, MD
Phone
13831120299
Email
zrx@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ruixing Zhang, MD
First Name & Middle Initial & Last Name & Degree
Qun Zhao, MD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jufeng Wang, Master
Phone
13783583966
Email
13783583966@163.com
First Name & Middle Initial & Last Name & Degree
Jufeng Wang, Master
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Yang, MD
Phone
13666601475
Email
yangliuqq2003@163.com
First Name & Middle Initial & Last Name & Degree
Liu Yang, MD
Facility Name
Cancer Hospital of The University of Chinese Academy of Science
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieer Ying, MD
Phone
13858195803
Email
jieerying@aliyun.com
First Name & Middle Initial & Last Name & Degree
Jieer Ying, MD
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Jin, Master
Phone
13867656027
Email
302861459@qq.com
First Name & Middle Initial & Last Name & Degree
Jianying Jin, Master
12. IPD Sharing Statement
Learn more about this trial
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
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