A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

A Single-arm, Open-label, Single-center Phase Ib Study to Evaluate the Safety and Efficacy of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Advanced Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04331743
• Other study ID #: PLM60-HCC-201901/PRO
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 5, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2021
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Kun Lou
• Phone: 0311-67808817
• Email: loukun[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 1, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent from the patient;

• ECOG performance status of 0 or 1;

• Histologically/cytologically confirmed diagnosis of advanced HCC;

• Adequate washout period for previous anti-tumor therapy;

• Measurable disease according to RECIST v1.1;

• Life expectancy = 12 weeks;

• Adequate organ function;

• Child-Pugh grade A or partial grade B; BCLC stage B or C;V

Exclusion Criteria:

• Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of > 360 mg/m2 ;

• Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less;

• Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);

• Any history of other malignancy within 5 years;

• Untreated hepatitis infection;

• HIV positive;

• History of liver transplantation, severe cirrhosis, hepatic encephalopathy;

• Inadequate cardiac function;

• Pregnant or lactating women.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Liposome-entrapped Mitoxantrone Hydrochloride Injection
Intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limited toxicity (DLT)	To identify the dose-limited toxicity (DLT).	1year
Primary	Maximum tolerated dose (MTD)	To identify the maximum tolerated dose (MTD).	1 year
Primary	Recommended Phase II Dose (RP2D)	To identify the Recommended Phase II Dose (RP2D)	1 year
Secondary	Area under the plasma concentration versus time curve (AUC)	To preliminarily evaluate the AUC in patients with advanced HCC.	2 years
Secondary	Peak Plasma Concentration (Cmax)	To preliminarily evaluate Cmax in patients with advanced HCC.	2 years
Secondary	Time of peak plasma concentration (Tmax)	To preliminarily evaluate Tmax in patients with advanced HCC.	2 years
Secondary	Median overall survival (OS)	To preliminarily evaluate ORR in patients with advanced HCC.	2 years
Secondary	Median progression free survival (PFS)	To preliminarily evaluate PFS in patients with advanced HCC.	2 years
Secondary	Overall response rate (ORR)	To preliminarily evaluate ORR in patients with advanced HCC.	2 years
Secondary	Duration of Response (DoR)	To preliminarily evaluate DoR in patients with advanced HCC.	2 years