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

NCT ID: NCT04719065

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2024-04-13

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.

Detailed Description

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. 90 subjects will be recruited. The first 60 subjects will be randomly assigned into 2 groups, group A and group B. The 30 subjects in group A will receive the Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 28 days (q4w, 1 cycle). The 30 subjects in group B will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, every 21 days (q3w, 1 cycle). After this, the last 30 subjects will be assigned into group B. All subjects will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or subject decision (a maximum of 8 cycles). Delays in drug administration is allowed from cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after cycle 2 is permitted, and the minimum dose is 12 mg/m2.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A, Mitoxantrone Hydrochloride Liposome Injection, q4w

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.

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Intervention Type: DRUG

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

Group B, Mitoxantrone Hydrochloride Liposome Injection, q3w

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.

Group Type: EXPERIMENTAL

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

Intervention Type: DRUG

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

Interventions

Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects fully understand and voluntarily participate in this study and sign informed consent;

2. Age ≥18, without gender limitation;

3. Histologically and/or cytologically confirmed diagnosis of unresectable local or metastasizing advanced solid tumor;

4. Fail to respond to standard therapy or lack of effective treatment, including no standard therapy, intolerance of standard therapy, etc.;

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

6. ECOG performance status of 0 or 1;

7. 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);

8. Adequate organ function;

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

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

4. History of allotransplantation;

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

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

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

8. Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;

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

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

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

12. Impaired cardiac function or serious cardiac disease;

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

14. Life expectancy<12 weeks;

15. Pregnant or lactating female;

16. Serious and/or uncontrolled systemic diseases;

17. Not suitable for this study as decided by the investigator due to other reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehui Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

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

Guangzhou, Guangdong, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

HE071-CSP-017

Identifier Type: -

Identifier Source: org_study_id