Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Gastrointestinal stromal tumors Exon 9 Gleevec Imatinib blood levels
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.

Detailed description:

Arms:
arm 1: Patients with blood level less than 1100 will continue imatinib 400 mg daily arm 2: Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL arm 3: Patients with blood level ≥1100 will continue imatinib 400 mg daily arm 4: Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily

Interventions: intervention 1: Imatinib mesylate intervention 2: Imatinib mesylate intervention 3: Imatinib mesylate
Intervention descriptions: intervention 1: 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops intervention 2: 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops intervention 3: 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Protocol document: