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Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib TDM | Experimental | Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 | To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients achieving therapeutic levels of imatinib. | Percent of patients achieving therapeutic levels of imatinib. | 6 months |
| Quality of Life based on the EORTC QLQ-C30 | Quality of Life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. It incorporates five functional scales, three symptom scales, a global health status, financial impact, and single items assessing additional symptoms. All scales and single-item measures are transformed so that scores range from 0-100; higher scores represent a higher response level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yvonne A Taul, RN | Contact | 859-323-2354 | Yvonne.Taul@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Reema Patel, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center | Recruiting | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| 6 months |
| Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years | 3 year |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |