Status:
COMPLETED
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
Lead Sponsor:
Pfizer
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00137449
Start Date
September 1 2005
End Date
April 1 2008
Last Update
September 15 2009
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
2
Pfizer Investigational Site
Lyon, France, 69373
3
Pfizer Investigational Site
Villejuif, France, 94805
4
Pfizer Investigational Site
Milan, Italy, 20133