Antineoplastic Drugs in Elderly Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467189
• Other study ID #: Elderly-Antineoplastic drugs
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: July 2022
• Source: Shandong University
• Contact: Zhao Wei, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)
As part of routine treatment.

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Shandong Provincial Qianfoshan Hospital, The Affiliated Hospital of Qingdao University, The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The peak plasma drug concentration of antineoplastic drugs.	To detect the peak plasma drug concentration of antineoplastic drugs.	at (0-4) hours after administration
Primary	The random plasma drug concentration of antineoplastic drugs.	To detect the random plasma drug concentration of antineoplastic drugs.	at (4-10) hours after administration
Primary	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	Objective ResponseRate ,ORR		Enrollment to end of treatment up to 5 years
Secondary	Overall Survival ,OS		First day of study treatment to the date of death due to any cause, assessed up to 5 years
Secondary	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
Secondary	Time to Progression ,TTP		Enrollment to end of treatment up to 5 years
Secondary	The incidence of adverse drug reaction		Enrollment to end of treatment up to 5 years