Drug: |
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Trial Name: |
Imatinib TDM (Therapeutic Drug Monitoring) in GIST |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Recruiting |
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Phase: |
2 |
Start Date 03/26/2024 |
Age of Trial (yrs) .5 |
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Treatment Phase: |
First-line
Adjuvant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
MCC-22-GI-123 |
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Sponsor: |
Reema A. Patel, MD, University of Kentucky |
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Patient Contact: |
Yvonne A Taul, RN
859-323-2354
Yvonne.Taul@uky.edu |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
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. 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 |
Trial Links |
Trial Results |
Name |
Address |
City |
State |
Zip |
Country |
800 Rose St. |
Lexington |
KY |
40536 |
USA |