At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
SU011248drug
Likely dose
37.5 mg once daily on a continuous daily dosing scheduleAI-extracted
Key inclusion· 4
- ✓Histopathologically confirmed diagnosis of malignant GIST not amenable to standard therapy
- ✓Failed prior imatinib therapy due to progression (RECIST/WHO criteria) or significant toxicity that prevented continued treatment
- ✓Documented intolerance to imatinib: Grade 4 toxicity at any dose, or unacceptable Grade 2 toxicity at moderate dose (e.g., 400 mg/day) despite countermeasures
- ✓Unidimensionally measurable disease
Key exclusion· 6
- ✕Prior treatment on a SU011248 (sunitinib) clinical trial
- ✕Second malignancy within last 3 years (except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma without recurrence for 12 months)
- ✕History of or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
- ✕Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, heart failure, stroke/TIA, or pulmonary embolism within 12 months prior to treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor
In Brief
A Phase 2 clinical trial evaluating SU011248 for Gastrointestinal Stromal Tumors. Completed, enrolled 60 participants across 4 sites in 3 countries.
Detailed Summary
To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesFrance, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartSep 2005
Primary CompletionApr 2008
TodayJul 2026
First PostedAug 29, 2005
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago
Interventions
SU011248drug
37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.