Antineoplastic Drugs in Elderly Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment<br>The use of antineoplastic agents depends on the clinical practice. | Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)<br>* As part of routine treatment.<br>* Other names: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective ResponseRate ,ORR |  | 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 | 
| Time to Progression ,TTP |  | Enrollment to end of treatment up to 5 years | 
| The incidence of adverse drug reaction |  | Enrollment to end of treatment up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Population Pharmacokinetics, Effectiveness, Safety, Antineoplastic Drugs, Elderly Patients