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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04331743
Collaborator
(none)
18
Enrollment
1
Arm
23.9
Anticipated Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 5, 2021
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: PLM60

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).

Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection
Intravenous infusion
Other Names:
  • PLM60
  • Outcome Measures

    Primary Outcome Measures

    1. Dose-limited toxicity (DLT) [1year]

      To identify the dose-limited toxicity (DLT).

    2. Maximum tolerated dose (MTD) [1 year]

      To identify the maximum tolerated dose (MTD).

    3. Recommended Phase II Dose (RP2D) [1 year]

      To identify the Recommended Phase II Dose (RP2D)

    Secondary Outcome Measures

    1. Area under the plasma concentration versus time curve (AUC) [2 years]

      To preliminarily evaluate the AUC in patients with advanced HCC.

    2. Peak Plasma Concentration (Cmax) [2 years]

      To preliminarily evaluate Cmax in patients with advanced HCC.

    3. Time of peak plasma concentration (Tmax) [2 years]

      To preliminarily evaluate Tmax in patients with advanced HCC.

    4. Median overall survival (OS) [2 years]

      To preliminarily evaluate ORR in patients with advanced HCC.

    5. Median progression free survival (PFS) [2 years]

      To preliminarily evaluate PFS in patients with advanced HCC.

    6. Overall response rate (ORR) [2 years]

      To preliminarily evaluate ORR in patients with advanced HCC.

    7. Duration of Response (DoR) [2 years]

      To preliminarily evaluate DoR in patients with advanced HCC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04331743
    Other Study ID Numbers:
    • PLM60-HCC-201901/PRO
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Jun 16, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2021