Antineoplastic Drugs in Elderly Patients

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05467189
Collaborator
Qianfoshan Hospital (Other), The Second Hospital of Shandong University (Other), The Affiliated Hospital of Qingdao University (Other)
500
1
89.9
5.6

Study Details

Study Description

Brief Summary

The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.

Condition or Disease Intervention/Treatment Phase
  • Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2028
Anticipated Study Completion Date :
Jun 30, 2028

Arms and Interventions

Arm Intervention/Treatment
treatment

The use of antineoplastic agents depends on the clinical practice.

Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)
As part of routine treatment.
Other Names:
  • Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc
  • Outcome Measures

    Primary Outcome Measures

    1. The peak plasma drug concentration of antineoplastic drugs. [at (0-4) hours after administration]

      To detect the peak plasma drug concentration of antineoplastic drugs.

    2. The random plasma drug concentration of antineoplastic drugs. [at (4-10) hours after administration]

      To detect the random plasma drug concentration of antineoplastic drugs.

    3. The trough plasma drug concentration of antineoplastic drugs. [at (1-2) hours before the next administration]

      To detect the trough plasma drug concentration of antineoplastic drugs.

    Secondary Outcome Measures

    1. Objective ResponseRate ,ORR [Enrollment to end of treatment up to 5 years]

    2. Overall Survival ,OS [First day of study treatment to the date of death due to any cause, assessed up to 5 years]

    3. Progression-free Survival ,PFS [First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years]

    4. Time to Progression ,TTP [Enrollment to end of treatment up to 5 years]

    5. The incidence of adverse drug reaction [Enrollment to end of treatment up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Subjects must meet all of the following inclusion criteria to be enrolled in the study:
    1. Age ≥65 years old;

    2. Diagnosed with cancer;

    3. Using antineoplastic drugs for treatment.

    Exclusion Criteria:
    Subjects with any of the following criteria will not be enrolled in this study:
    1. Patients who are expected to die within 48 hours;

    2. Patients with allergy to antineoplastic drugs;

    3. Patients receiving other investigational drugs;

    4. Other factors that the researcher considers unsuitable for inclusion.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Provincial Qianfoshan Hospital Jinan Shandong China

    Sponsors and Collaborators

    • Shandong University
    • Qianfoshan Hospital
    • The Second Hospital of Shandong University
    • The Affiliated Hospital of Qingdao University

    Investigators

    • Study Chair: Zhao Wei, Ph.D, Qianfoshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
    ClinicalTrials.gov Identifier:
    NCT05467189
    Other Study ID Numbers:
    • Elderly-Antineoplastic drugs
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022