A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
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)
1 other identifier
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2021
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
June 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 16, 2021
June 1, 2021
1.9 years
March 12, 2020
June 14, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Dose-limited toxicity (DLT)
To identify the dose-limited toxicity (DLT).
1year
Maximum tolerated dose (MTD)
To identify the maximum tolerated dose (MTD).
1 year
Recommended Phase II Dose (RP2D)
To identify the Recommended Phase II Dose (RP2D)
1 year
Secondary Outcomes (7)
Area under the plasma concentration versus time curve (AUC)
2 years
Peak Plasma Concentration (Cmax)
2 years
Time of peak plasma concentration (Tmax)
2 years
Median overall survival (OS)
2 years
Median progression free survival (PFS)
2 years
- +2 more secondary outcomes
Study Arms (1)
PLM60
EXPERIMENTALThree 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).
Interventions
Intravenous infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
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
March 12, 2020
First Posted
April 2, 2020
Study Start
June 5, 2021
Primary Completion
May 15, 2023
Study Completion
June 1, 2023
Last Updated
June 16, 2021
Record last verified: 2021-06