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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

SU011248

Intervention Type DRUG

37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.

Interventions

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SU011248

37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No