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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
| The Second Hospital of Shandong University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | The use of antineoplastic agents depends on the clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs) | Drug | As part of routine treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Subjects with any of the following criteria will not be enrolled in this study:
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Elderly patients with cancer (≥65years)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Wei, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao Wei, Ph.D | Qianfoshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D017239 | Paclitaxel |
| D000077716 | Afatinib |
| C586847 | ceritinib |
| D000077547 | Crizotinib |
| D000970 | Antineoplastic Agents |
| D000068877 | Imatinib Mesylate |
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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 |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000577 | Amides |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D010879 | Piperazines |
| D011743 | Pyrimidines |