CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
SU011248 50 mg orally once daily (4 weeks on/2 weeks off in 6-week cycles)AI-extracted
Key inclusion· 2
  • ✓Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
  • ✓Failed prior imatinib (Gleevec) treatment or intolerant to Gleevec therapy
Key exclusion· 1
  • ✕Any prior chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075218
NCT00075218Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Pfizer·interventional·Posted Jan 8, 2004·Updated Sep 28, 2009

In Brief

A Phase 3 clinical trial evaluating Placebo and SU011248 for Gastrointestinal Stromal Tumor. Completed, enrolled 361 participants across 61 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumor
CountriesAustralia, Belgium, Canada, France, Italy, Netherlands, Singapore, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 8, 2004
Enrollment StartDec 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 22.5 years ago

Interventions

Placebodrug

50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

SU011248drug

50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.