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NCT Number: NCT05467189

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.

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Key information

Conditions

Cancer Neoplasms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Location status: Recruiting

Location contact

Zhao Wei, Ph.D

CONTACT

[email protected]

86053188383308

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be enrolled in the study:

  • Age ≥65 years old;
  • Diagnosed with cancer;
  • Using antineoplastic drugs for treatment.

Exclusion criteria

Subjects with any of the following criteria will not be enrolled in this study:

  • Patients who are expected to die within 48 hours;
  • Patients with allergy to antineoplastic drugs;
  • Patients receiving other investigational drugs;
  • Other factors that the researcher considers unsuitable for inclusion.

Treatment and study plan

Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)

Drug

As part of routine treatment.

Other names: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Objective ResponseRate ,ORR

    Time frame: Enrollment to end of treatment up to 5 years

  2. Overall Survival ,OS

    Time frame: First day of study treatment to the date of death due to any cause, assessed up to 5 years

  3. 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

  4. Time to Progression ,TTP

    Time frame: Enrollment to end of treatment up to 5 years

  5. The incidence of adverse drug reaction

    Time frame: Enrollment to end of treatment up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhao Wei, Ph.D

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2022
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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