Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo

+ SU011248

Drug
Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorPfizer
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00085618NCT00075218
Principal SponsorPfizer
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

361 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal Stromal Tumors

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 61 locations

Suspended

Pfizer Investigational Site

Duarte, United StatesSee the location
Suspended

Pfizer Investigational Site

Los Angeles, United States
Suspended

Pfizer Investigational Site

Los Angeles, United States
Suspended

Pfizer Investigational Site

Pasadena, United States
Completed61 Study Centers