Antineoplastic Drugs in Elderly Patients

July 18, 2022 updated by: Wei Zhao, Shandong University

Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Qianfoshan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with cancer (≥65years)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The peak plasma drug concentration of antineoplastic drugs.
Time Frame: at (0-4) hours after administration
To detect the peak plasma drug concentration of antineoplastic drugs.
at (0-4) hours after administration
The random plasma drug concentration of antineoplastic drugs.
Time Frame: at (4-10) hours after administration
To detect the random plasma drug concentration of antineoplastic drugs.
at (4-10) hours after administration
The trough plasma drug concentration of antineoplastic drugs.
Time Frame: at (1-2) hours before the next administration
To detect the trough plasma drug concentration of antineoplastic drugs.
at (1-2) hours before the next administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective ResponseRate ,ORR
Time Frame: Enrollment to end of treatment up to 5 years
Enrollment to end of treatment up to 5 years
Overall Survival ,OS
Time Frame: First day of study treatment to the date of death due to any cause, assessed up to 5 years
First day of study treatment to the date of death due to any cause, assessed up to 5 years
Progression-free Survival ,PFS
Time Frame: First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years
First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years
Time to Progression ,TTP
Time Frame: Enrollment to end of treatment up to 5 years
Enrollment to end of treatment up to 5 years
The incidence of adverse drug reaction
Time Frame: Enrollment to end of treatment up to 5 years
Enrollment to end of treatment up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

March 30, 2028

Study Completion (Anticipated)

June 30, 2028

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elderly-Antineoplastic drugs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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