Imatinib TDM in GIST

Launched by REEMA A. PATEL · Aug 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called imatinib for patients with gastrointestinal stromal tumors (GIST), a type of tumor found in the digestive system. Imatinib can help patients live longer without their cancer coming back, but it can also cause side effects that affect their daily life. The goal of this study is to monitor the levels of imatinib in patients to ensure they are getting the right amount, which may help improve their quality of life and manage symptoms better.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of GIST with certain genetic mutations. They should also be starting imatinib treatment either within the last three months or soon. Participants will be closely monitored throughout the study, which means regular check-ups to see how well the treatment is working and to manage any side effects. This trial is currently recruiting and aims to help improve the experience of patients undergoing treatment for GIST.

Gender

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Eligibility criteria

• 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