A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04718402
Collaborator
(none)
30
Enrollment
9
Locations
1
Arm
33.7
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection
Phase 1

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Jan 19, 2022
Anticipated Study Completion Date :
Jan 19, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mitoxantrone Hydrochloride Liposome Injection

Subjects with advanced gastric carcinoma will receive 20mg/m2Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles.

Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).

Outcome Measures

Primary Outcome Measures

  1. adverse events (AEs) [From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months]

    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

  1. overall response rate (ORR) [From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)]

    To investigate the preliminary antitumor efficacy

  2. duration of response (DoR) [From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months]

    To investigate the preliminary antitumor efficacy

  3. duration of complete response (DCR) [From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)]

    To investigate the preliminary antitumor efficacy

  4. progression-free survival (PFS) [From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months]

    To investigate the preliminary antitumor efficacy

  5. overall survival (OS) [From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months]

    To investigate the preliminary antitumor efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Subjects fully understand and voluntarily participate in this study and sign informed consent;

  2. Age ≥18, without gender limitation;

  3. Histologically confirmed diagnosis of unresectable locally advanced or metastatic gastric carcinoma, including gastroesophageal junction carcinoma;

  4. Suitable to receive the study drug as decided by the investigator;

  5. At least one measurable lesion according to RECIST v1.1;

  6. ECOG performance status of 0 to 2;

  7. Life expectancy ≥ 12 weeks;

  8. 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);

  9. Adequate organ function;

  10. Subjects of childbearing potential must agree to use effective contraceptive measures. Female subjects must have a negative pregnancy test before enrolment;

  11. Fully comply with the protocol.

Exclusion Criteria:
  1. History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;

  2. Untreated or symptomatic central nervous system (CNS) metastases;

  3. Amenable to curative surgery ( radical excision);

  4. 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);

  5. Intestinal obstruction with overt clinical symptom and requiring treatment;

  6. CTCAE Grade 3 or Grade 4 gastrointestinal hemorrhage within 12 weeks prior to the first dose administration;

  7. History of allotransplantation;

  8. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;

  9. Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;

  10. Use of other anticancer treatment within 4 weeks prior to the first dose administration;

  11. Enrolled in any other clinical trails and had recieved treatment within 4 weeks prior to the first dose administration;

  12. Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;

  13. Thrombosis or thromboembolism within 6 months prior to screening;

  14. History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;

  15. Impaired cardiac function or serious cardiac disease;

  16. Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2.

  17. Pregnant or lactating female;

  18. Serious and/or uncontrolled systemic diseases;

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Beijing Luhe Hospital Capital Medical UniversityBeijingBeijingChina101149
2Fujian Cancer HospitalFuzhouFujianChina350011
3Lanzhou University Second HospitalLanzhouGansuChina730030
4Hebei General HospitalShijiazhuangHebeiChina050000
5The Fourth Hospital of Hebei Medical University and Hebei Cancer HospitalShijiazhuangHebeiChina050019
6Henan Cancer HospitalZhengzhouHenanChina450000
7Zhejiang Provincial People's HospitalHangzhouZhejiangChina310014
8Cancer Hospital of The University of Chinese Academy of ScienceHangzhouZhejiangChina310022
9Taizhou Hospital of Zhejiang ProvinceTaizhouZhejiangChina317000

Sponsors and Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Principal Investigator: Jieer Ying, Doctor, Cancer Hospital of The University of Chinese Academy of Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04718402
Other Study ID Numbers:
  • HE071-CSP-014
First Posted:
Jan 22, 2021
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2021