Back to resultsA Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Liposome-entrapped Mitoxantrone Hydrochloride Injection
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PLM60
Arm Description
Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days).
Outcomes
Primary Outcome Measures
Dose-limited toxicity (DLT)
To identify the dose-limited toxicity (DLT).
Maximum tolerated dose (MTD)
To identify the maximum tolerated dose (MTD).
Recommended Phase II Dose (RP2D)
To identify the Recommended Phase II Dose (RP2D)
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced HCC.
Peak Plasma Concentration (Cmax)
To preliminarily evaluate Cmax in patients with advanced HCC.
Time of peak plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced HCC.
Median overall survival (OS)
To preliminarily evaluate ORR in patients with advanced HCC.
Median progression free survival (PFS)
To preliminarily evaluate PFS in patients with advanced HCC.
Overall response rate (ORR)
To preliminarily evaluate ORR in patients with advanced HCC.
Duration of Response (DoR)
To preliminarily evaluate DoR in patients with advanced HCC.
Full Information
NCT ID
NCT04331743
First Posted
March 12, 2020
Last Updated
June 14, 2021
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04331743
Brief Title
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2021 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PLM60
Arm Type
Experimental
Arm Description
Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days).
Intervention Type
Drug
Intervention Name(s)
Liposome-entrapped Mitoxantrone Hydrochloride Injection
Other Intervention Name(s)
PLM60
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limited toxicity (DLT)
Description
To identify the dose-limited toxicity (DLT).
Time Frame
1year
Title
Maximum tolerated dose (MTD)
Description
To identify the maximum tolerated dose (MTD).
Time Frame
1 year
Title
Recommended Phase II Dose (RP2D)
Description
To identify the Recommended Phase II Dose (RP2D)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
To preliminarily evaluate the AUC in patients with advanced HCC.
Time Frame
2 years
Title
Peak Plasma Concentration (Cmax)
Description
To preliminarily evaluate Cmax in patients with advanced HCC.
Time Frame
2 years
Title
Time of peak plasma concentration (Tmax)
Description
To preliminarily evaluate Tmax in patients with advanced HCC.
Time Frame
2 years
Title
Median overall survival (OS)
Description
To preliminarily evaluate ORR in patients with advanced HCC.
Time Frame
2 years
Title
Median progression free survival (PFS)
Description
To preliminarily evaluate PFS in patients with advanced HCC.
Time Frame
2 years
Title
Overall response rate (ORR)
Description
To preliminarily evaluate ORR in patients with advanced HCC.
Time Frame
2 years
Title
Duration of Response (DoR)
Description
To preliminarily evaluate DoR in patients with advanced HCC.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Lou
Phone
0311-67808817
Email
loukun@mail.ecspc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
010-63930702
Email
xiaxuefang@mail.ecspc.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
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