CancerNCT05467189
Antineoplastic Drugs in Elderly Patients
An observational study of Cancer, run by Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2028
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with cancer (≥65years)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Zhao Wei, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
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
- Being tested
- Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)
- Keywords
- Population Pharmacokinetics, Effectiveness, Safety, Antineoplastic Drugs, Elderly Patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)Drug
Also called Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc
As part of routine treatment.
| Study group | Role | What they receive |
|---|---|---|
| treatment | The use of antineoplastic agents depends on the clinical practice. Receives: Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak plasma drug concentration of antineoplastic drugs.
To detect the peak plasma drug concentration of antineoplastic drugs.
Measured: at (0-4) hours after administration
The random plasma drug concentration of antineoplastic drugs.
To detect the random plasma drug concentration of antineoplastic drugs.
Measured: at (4-10) hours after administration
The trough plasma drug concentration of antineoplastic drugs.
To detect the trough plasma drug concentration of antineoplastic drugs.
Measured: at (1-2) hours before the next administration
Secondary outcomes (5)
Objective ResponseRate ,ORR
Measured: Enrollment to end of treatment up to 5 years
Overall Survival ,OS
Measured: First day of study treatment to the date of death due to any cause, assessed up to 5 years
Progression-free Survival ,PFS
Measured: 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
Measured: Enrollment to end of treatment up to 5 years
The incidence of adverse drug reaction
Measured: Enrollment to end of treatment up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jan 2021
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Zhao Wei, Ph.D, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467189
- Sponsor's protocol ID
- Elderly-Antineoplastic drugs
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics, Effectiveness and Safety of Antineoplastic Drugs in Elderly Patients
- ClinicalTrials.gov ID
- NCT05467189
- Acronym / sponsor ID
- Elderly-Antineoplastic drugs
- Conditions
- Cancer
- Keywords
- Population Pharmacokinetics, Effectiveness, Safety, Antineoplastic Drugs, Elderly Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | – | Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)The use of antineoplastic agents depends on the clinical practice. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with cancer (≥65years)
Key inclusion criteria (4 listed)
- Age ≥65 years old;
- Diagnosed with cancer;
- Using antineoplastic drugs for treatment.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)Also: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etcAs part of routine treatment. | Drug | treatment |
Primary outcome
The peak plasma drug concentration of antineoplastic drugs.
Time frame: at (0-4) hours after administration
To detect the peak plasma drug concentration of antineoplastic drugs.
The random plasma drug concentration of antineoplastic drugs.
Time frame: at (4-10) hours after administration
To detect the random plasma drug concentration of antineoplastic drugs.
The trough plasma drug concentration of antineoplastic drugs.
Time frame: at (1-2) hours before the next administration
To detect the trough plasma drug concentration of antineoplastic drugs.
5 secondary outcomes
Objective ResponseRate ,ORR
Time frame: Enrollment to end of treatment up to 5 years
Overall Survival ,OS
Time frame: First day of study treatment to the date of death due to any cause, assessed up to 5 years
Progression-free Survival ,PFS
Time frame: 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
Time frame: Enrollment to end of treatment up to 5 years
The incidence of adverse drug reaction
Time frame: Enrollment to end of treatment up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Wei, Ph.D study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wei, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak plasma drug concentration of antineoplastic drugs. (time frame: at (0-4) hours after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.