Phase 3
N=361
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
Gastrointestinal Stromal Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00075218 ↗Enrolled (actual)
361
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase — 27.3; 6.4 weeks — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); SU011248 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase |
27.3; 6.4 | <0.001 sig |
| PRIMARY Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study |
26.6; 6.4 | <0.001 sig |
| SECONDARY Progression Free Survival (PFS) |
22.9; 6.0 | <0.001 sig |
| SECONDARY Overall Survival Status of Subjects |
176; 90; 67; 28 | — |
| SECONDARY Overall Survival |
72.7; 64.9 | 0.306 |
| SECONDARY Overall Survival Based on the Rank Preserving Structural Failure Time Method |
72.7; 39.0 | 0.306 |
| SECONDARY Best Overall Tumor Response During Double-blind Treatment Phase |
0; 0; 16; 0; 128; 50 | — |
| SECONDARY Confirmed Objective Response (CR or PR) in Subjects |
16; 0 | 0.004 sig |
| SECONDARY Time to Tumor Response (TTR) |
13.4 | — |
| SECONDARY Duration of Performance Status Maintenance |
18.9 | — |
| SECONDARY Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) |
12.1 | 0.9322 |
| SECONDARY Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) |
46; 10 | 0.0046 sig |
| SECONDARY Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) |
-3.0; 0.0; 0.0; 0.0; -4.5; 0.0 | — |
| SECONDARY Change From Baseline in EQ-5D Health State Profile Index |
0.000; 0.000; 0.000; 0.000; -0.017; 0.000 | — |
Summary
A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.
Eligibility Criteria
Key Inclusion Criteria
- Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
- Failed Gleevec treatment or intolerant to Gleevec therapy
Key Exclusion Criteria
- Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
Data sourced from ClinicalTrials.gov (NCT00075218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.