Gastrointestinal Stromal Tumors
Conditions
Brief summary
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.
Interventions
DRUGImatinib
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
Sponsors
Reema A. Patel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V) * Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month * Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease * Age ≥18 years * ECOG performance status of 0 or 1 * Normal organ function
Exclusion criteria
* Presence of PDGFRA D842V mutation * Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug * Concomitant anticoagulation with oral warfarin. * Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6 * Uncontrolled intercurrent illness * Concurrent malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients achieving therapeutic levels of imatinib. | 6 months | Percent of patients achieving therapeutic levels of imatinib. |
| Quality of Life based on the EORTC QLQ-C30 | 6 months | 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. |
| Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years | 3 year | — |
Countries
United States
Contacts
CONTACTYvonne A Taul, RN
PRINCIPAL_INVESTIGATORReema Patel, MD
University of Kentucky
Outcome results
None listed