Antineoplastic Drugs in Elderly Patients

NCT05467189 | Recruiting FDA Drug

• 1 other identifier: Elderly-Antineoplastic drugs
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

treatment

The use of antineoplastic agents depends on the clinical practice.

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

Interventions

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

As part of routine treatment.

Also known as: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc

treatment

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients with cancer (≥65years)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead
• Qianfoshan Hospital: collaborator
• The Second Hospital of Shandong University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Busulfan; Paclitaxel; Afatinib; ceritinib; Crizotinib; Antineoplastic Agents; Imatinib Mesylate; Lapatinib

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Amides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Aminopyridines; Pyridines; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Piperazines; Pyrimidines

Study Officials

• Zhao Wei, Ph.D

  Qianfoshan Hospital

  STUDY CHAIR

Central Study Contacts

Zhao Wei, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 20, 2022
• Study Start: January 1, 2021
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)