Antineoplastic Drugs in Elderly Patients

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05467189

Enrollment

500

Registered

2022-07-20

Start date

2021-01-01

Completion date

2028-06-30

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Population Pharmacokinetics, Effectiveness, Safety, Antineoplastic Drugs, Elderly Patients

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.

Interventions

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

As part of routine treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The peak plasma drug concentration of antineoplastic drugs.	at (0-4) hours after administration	To detect the peak plasma drug concentration of antineoplastic drugs.
The random plasma drug concentration of antineoplastic drugs.	at (4-10) hours after administration	To detect the random plasma drug concentration of antineoplastic drugs.
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

Measure	Time frame
Time to Progression ,TTP	Enrollment to end of treatment up to 5 years
Objective ResponseRate ,ORR	Enrollment to end of treatment up to 5 years
The incidence of adverse drug reaction	Enrollment to end of treatment up to 5 years
Overall Survival ,OS	First day of study treatment to the date of death due to any cause, assessed up to 5 years
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

Countries

China

Contacts

Primary ContactZhao Wei, Ph.D

zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026