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A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

Phase 2
18 Years
Not Enrolling
Gastrointestinal Stromal Tumors

Thank you

Trial Information

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

Subjects experiencing clinical benefit after 1 year on study were offered continued
treatment with SU011248 on a separate protocol.

Inclusion Criteria:

- Histopathologically proven diagnosis of malignant GIST that was not amenable to
standard therapy.

- Failed prior treatment with imatinib mesylate, defined either by progression of
disease (according to Response Evaluation Criterion in Solid Tumors (RECIST)
or World Health Organization (WHO) criteria), or by significant toxicity during
treatment with imatinib mesylate that precluded further treatment. Intolerance to
prior imatinib mesylate therapy was defined as follows:

- Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or
rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg,
400 mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient
(such as nausea) that persisted despite standard countermeasures

- Evidence of unidimensionally measurable disease.

Exclusion Criteria:

- Previous treatment on a SU011248 clinical trial.

- Diagnosis of any second malignancy within the last 3 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately
treated with no evidence of recurrent disease for 12 months.

- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease.

- Any of the following within the 12 months prior to starting the study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident or transient ischemic
attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
interval >450 msec for males or >470 msec for females.

- Hypertension that could not be controlled by medications (>150/100 mm/Hg despite
optimal medical therapy).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Clinical Benefit Response (CBR) According to RECIST

Outcome Time Frame:

Planned duration on this protocol of up to 1 year

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

April 2008

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Stromal Tumors



Pfizer Investigational Site North Adams, Massachusetts  01247