Antineoplastic Drugs in Elderly Patients

Recruiting

• Conditions: Cancer
• Interventions: Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)

• Registration Number: NCT05467189
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2028-03-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treatment	Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)	The use of antineoplastic agents depends on the clinical practice.

Primary Outcome Measures

Name	Time	Method
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.
The peak plasma drug concentration of antineoplastic drugs.	at (0-4) hours after administration	To detect the peak plasma drug concentration of antineoplastic drugs.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China