Studying cancer drug effectiveness and safety in elderly patients
Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
This study is testing how well and safely different cancer drugs work for older patients aged 65 and up to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Drugs / interventions | Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05467189 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the population pharmacokinetics, effectiveness, and safety of various antineoplastic drugs, including Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, and Lapatinib, specifically in elderly patients aged 65 and older diagnosed with cancer. The study will analyze how these drugs behave in this population and recommend optimized dosage regimens to enhance treatment outcomes. By focusing on the elderly, the study addresses a critical gap in cancer treatment, as this demographic often responds differently to medications compared to younger patients.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who have been diagnosed with cancer and are currently using antineoplastic drugs.
Not a fit: Patients who are expected to die within 48 hours or have allergies to antineoplastic drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer cancer treatments tailored for elderly patients.
How similar studies have performed: While there is ongoing research into cancer treatments for the elderly, this specific focus on population pharmacokinetics and optimized dosing regimens for a range of antineoplastic drugs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Zhao Wei, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.