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

NCT04718402 | Terminated Phase 1

• 1 other identifier: HE071-CSP-014
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 9

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.

Conditions

Advanced Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  From the initiation of the first dose to 28 days after the last dose, assessed up to 36 months

Secondary Outcomes (5)

• overall response rate (ORR)

  From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)

• 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

• duration of complete response (DCR)

  From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)

• 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

• overall survival (OS)

  From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

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

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection DRUG

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

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (9)

Beijing Luhe Hospital Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

Location

The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital

Shijiazhuang, Hebei, 050019, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Cancer Hospital of The University of Chinese Academy of Science

Hangzhou, Zhejiang, 310022, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

MeSH Terms

Interventions

Injections, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Jieer Ying, Doctor

  Cancer Hospital of The University of Chinese Academy of Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 22, 2021
• Study Start: March 30, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: March 7, 2024

Record last verified: 2021-05

Locations

CN (9)