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PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05848648
Collaborator
(none)
50
Enrollment
37
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation.

    Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Jun 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Blood drug concentration [6 months]

      After treating with Pamipali, blood samples were collected at different time periods

    Secondary Outcome Measures

    1. Correlation between blood drug concentration and adverse events [6 months]

      Try to find the relationship between pharmacokinetic parameters and adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The age of the patient is ≥ 18 years old and less than 80 years old.

    2. Receive treatment with pamipalil.

    3. The patient signed a written informed consent form.

    Exclusion Criteria:

    1. The expected survival time may be less than the treatment cycle.

    2. Is being treated with other systemic trial drugs.

    3. There are other factors that the researchers think are not suitable for joining the group.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qianfoshan Hospital

    Investigators

    • Study Director: Huang Xin, Qianfoshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xin Huang, Chief pharmacist, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05848648
    Other Study ID Numbers:
    • QFS-HX-2023-PMPL-001
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xin Huang, Chief pharmacist, Qianfoshan Hospital
    Ovarian Cancer
    Pamiparib
    Additional relevant MeSH terms:
    Ovarian Neoplasms

    Study Results

    No Results Posted as of May 8, 2023