Gastrointestinal Stromal Tumors
Conditions
Keywords
GIST, Gastrointestinal stromal tumors, Exon 9, Gleevec, Imatinib blood levels
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.
Interventions
DRUGImatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Sponsors
Novartis Pharmaceuticals
Sarcoma Alliance for Research through Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Unresectable and/or metastatic GIST * Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST * For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST * Good physical functioning (ECOG Performance Status of 0 or 1) * Generally, good function of organ such as liver and kidneys
Exclusion criteria
* Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST) * Known intolerance of imatinib at a dose of 400 mg/day or higher * Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease * Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery * Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon) * Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks or who have not recovered from side effects of this therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Lesions for Progression or Response Via RECIST Criteria | Every 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | 0 |
| Arm B Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | 1 |
| Arm C Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | 3 |
| Arm D Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | 0 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Study terminated early | 0 | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Arm C | Total | Arm B |
|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 0 participants | 1 participants | 1 participants |
| Age Categorical Between 18 and 65 years | 3 participants | 3 participants | 0 participants |
| Age Continuous | 56.7 years STANDARD_DEVIATION 8.39 | 60.25 years STANDARD_DEVIATION 7.68 | 71 years |
| Gender Female | 1 participants | 2 participants | 1 participants |
| Gender Male | 2 participants | 2 participants | 0 participants |
| Region of Enrollment United States | 3 participants | 4 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 1 / 1 | 2 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 3 | 0 / 0 |
Outcome results
Primary
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Time frame: Every 3 months
Population: Data were not collected or analyzed due to early termination.