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

Advanced Solid Tumor Clinical Trial

Official title:

A Multicenter, Randomized, Open-label, Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Solid Tumor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04719065
• Other study ID #: HE071-CSP-017
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 13, 2021
• Est. completion date: April 13, 2024

Study information

• Verified date: August 2021
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 13, 2024
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	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	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Yibin Second People's Hospital	Yibin	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall response rate (ORR)	To investigate the preliminary antitumor efficacy	From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Secondary	duration of response (DoR)	To investigate the preliminary antitumor efficacy	From the enrollment to CR,PR, PD, death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Secondary	duration of complete response (DCR)	To investigate the preliminary antitumor efficacy	From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
Secondary	progression-free survival (PFS)	To investigate the preliminary antitumor efficacy	From the enrollment to CR,PR, PD, death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Secondary	overall survival (OS)	To investigate the preliminary antitumor efficacy	From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
Secondary	maximum time (Tmax)	To investigate PK characteristics	Cycle 1 to cycle 4, approximately 16 weeks
Secondary	maximum concentration (Cmax)	To investigate PK characteristics	Cycle 1 to cycle 4, approximately 16 weeks
Secondary	area under the plasma concentration-time curve from time zero to the time of last observed concentration (AUC0-t)	To investigate PK characteristics	Cycle 1 to cycle 4, approximately 16 weeks
Secondary	apparent terminal half-life (t1/2)	To investigate PK characteristics	Cycle 1 to cycle 4, approximately 16 weeks