Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

Completed · Phase 2

Conditions studied: Gastrointestinal Stromal Tumors

In brief

To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

Key facts

Study ID

NCT00137449

Run by

Pfizer

People needed

60

Starts

2005-09-01

Expected to finish

2008-04-01

Last updated by the study team

2009-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Lyon, France
• Pfizer Investigational Site — Villejuif, France
• Pfizer Investigational Site — Milan, Italy

Full record on ClinicalTrials.gov

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