A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor

NCT04719065 | Unknown Phase 1

• 1 other identifier: HE071-CSP-017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced solid tumor.

Conditions

Advanced Solid Tumor

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 first dose injection to 28 days after the last dose injection, assessed up to 36 weeks

Secondary Outcomes (9)

• 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 CR,PR, PD, 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 CR,PR, PD, death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months

• overall survival (OS)

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

Study Arms (2)

Group A, Mitoxantrone Hydrochloride Liposome Injection, q4w

EXPERIMENTAL

Subjects with advanced or metastatic solid tumor will receive Mitoxantrone Hydrochloride Liposome every 28 days (a cycle) for a maximum of 8 cycles. The starting dose of Mitoxantrone Hydrochloride Liposome is 20mg/m2.

Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Group B, Mitoxantrone Hydrochloride Liposome Injection, q3w

EXPERIMENTAL

Subjects with advanced or metastatic solid tumor will receive Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles. The starting dose of Mitoxantrone Hydrochloride Liposome is 20mg/m2.

Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) DRUG

Subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/ m2, IV, on day 1 of each cycle for a maximum of 8 cycles.

Group A, Mitoxantrone Hydrochloride Liposome Injection, q4w; Group B, Mitoxantrone Hydrochloride Liposome Injection, q3w

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 and/or cytologically confirmed diagnosis of unresectable local or metastasizing advanced solid tumor;
• Fail to respond to standard therapy or lack of effective treatment, including no standard therapy, intolerance of standard therapy, etc.;
• At least one measurable lesion according to RECIST v1.1;
• ECOG performance status of 0 or 1;
• 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 enrollment;
• 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;
• 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 trials 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;
• Life expectancy\<12 weeks;
• Pregnant or lactating female;

Sponsors & Collaborators

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

Study Sites (8)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233099, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 511399, China

Location

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Yibin Second People's Hospital

Yibin, Sichuan, 644199, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Injections, Intravenous

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yehui Shi, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 22, 2021
• Study Start: January 13, 2021
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2024
• Last Updated: November 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)