A Study of Mitoxantrone Hydrochloride Liposome Injection in Chinese Patients With Advanced Solid Tumors

NCT04921878 | Completed Phase 1

• 1 other identifier: HE071-CSP-025
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limit toxicity (DLT)

  Up to 21 days after the first dose

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From the initiation of the first dose to 28 days after the last dose

Secondary Outcomes (12)

• Pharmacokinetic profile: Cmax

  Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)

• Pharmacokinetic profile: Tmax

  Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)

• Pharmacokinetic profile: AUC0-t

  Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)

• Pharmacokinetic profile: AUC0-∞

  Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)

• Pharmacokinetic profile: t1/2

  Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

Dose-escalation phase: Patients will receive mitoxantrone hydrochloride liposome injection followed by a 3-week DLT observation period. The initial dose of mitoxantrone hydrochloride liposome injection will be set as 24 mg/m2, and then the dose is sequentially escalated to 30 mg/m2, 36 mg/m2 and 40 mg/m2. Dose-expansion phase: After DLT observation, two to four dose cohorts will be selected for dose-expansion to further evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection.

Drug: Mitoxantrone Hydrochloride Liposome injection

Interventions

Mitoxantrone Hydrochloride Liposome injection DRUG

Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle) for a maximum of 6 cycles.

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

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

You may qualify if:

• Patients fully understand and voluntarily participate in this study and sign informed consent;
• Aged 18-65 years, without gender limitation;
• Histologically or cytologically confirmed advanced solid tumors;
• Patients with advanced solid tumors who have been judged by the investigator to be ineffective with conventional therapy or lacking effective treatment, including those for whom no current standard of care is available or for whom is unable to tolerate standard therapy, etc.;
• At least one measurable lesion according to RECIST v1.1 at baseline;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 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 alopecia, hyperpigmentation);
• Adequate organ function defined as:
• Absolute neutrophil count (ANC) ≥1.5\*109/L (No G-CSF treatment within 2 weeks prior to the laboratory test);
• Hemoglobin ≥ 90 g/L (No red blood cell transfusion within 2 weeks prior to the laboratory test);
• Platelet count ≥ 100\*109/L (No platelet transfusion within 2 weeks prior to the laboratory test);
• Creatinine ≤1.5 upper limit of normal (ULN);
• Total bilirubin ≤1.5 ULN;
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3 ULN;
• Coagulation: prothrombin time (PT) or International Normalization Ratio (INR) ≤1.5 ULN

You may not qualify if:

• History of severe allergy to mitoxantrone hydrochloride or any excipients of the study drug;
• Cerebral or meningeal metastases;
• Life expectancy \< 3 months;
• Patients with chronic hepatitis B (HBsAg or HBcAb positive with HBV DNA ≥ 1000 IU/mL), chronic hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
• Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
• Any anticancer treatment within 4 weeks prior to the first dose (e.g., radiotherapy, targeted therapy, immunotherapy, endocrine therapy, etc.); Traditional Chinese medicine or proprietary Chinese medicine with an approved oncology indication within 2 weeks prior to the first dose;
• Enrolled in any other clinical trials within 4 weeks prior to the first dose;
• Patients underwent major surgery within 3 months prior to the first dose did not fully recover, or have a surgical schedule during the study period;
• Serious thrombosis or thromboembolism as judged by the investigator within 6 months prior to screening;
• History of additional malignant tumor within 3 years, except for locally curable cancer that has been cured, such as basal or squamous cell skin cancer or in situ prostate, cervical or breast cancer;
• Patients with the following cardiac function defects:
• Long QTc syndrome or QTc interval \> 480 ms;
• Complete left bundle branch block, II-III degree atrioventricular block;
• Severe, uncontrolled arrhythmias requiring pharmacological treatment;
• History of chronic congestive heart failure, NYHA ≥ grade 3;

Sponsors & Collaborators

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

Study Sites (1)

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Location

Study Officials

• Aimin Zang, Master

  Affiliated Hospital of Hebei University

  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: May 31, 2021
• First Posted: June 10, 2021
• Study Start: July 30, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: February 9, 2024

Record last verified: 2021-06

Locations

CN (1)