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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137449
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : September 4, 2009
Last Update Posted : September 15, 2009
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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

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: SU011248 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor
Study Start Date : September 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: A Drug: 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.

Primary Outcome Measures :
  1. Number of Participants With Clinical Benefit Response (CBR) According to RECIST [ Time Frame: Planned duration on this protocol of up to 1 year ]

Secondary Outcome Measures :
  1. Number of Participants by Best Confirmed Response Category According to RECIST [ Time Frame: Planned duration on this protocol of up to 1 year ]
  2. Number of Participants With Overall Confirmed Objective Disease Response (ORR) [ Time Frame: Planned duration on this protocol of up to 1 year ]
  3. Duration of Stable Disease [ Time Frame: Planned duration on this protocol of up to 1 year ]
  4. Progression-free Survival (PFS) [ Time Frame: Planned duration on this protocol of up to 1 year ]
  5. Time to Tumor Progression (TTP) [ Time Frame: Planned duration on this protocol of up to 1 year ]
  6. Duration of Tumor Response (DR) [Descriptive Statistics] [ Time Frame: Planned duration on this protocol of up to 1 year ]
  7. Overall Survival (OS) and One-year Survival [Descriptive Statistics] [ Time Frame: Survival status was collected by telephone contact every 2 months for up to 2 years from study entry. ]
  8. Score of FACIT-Fatigue Scale [ Time Frame: Baseline, Day 1 & 15 of each treatment cycle ]
  9. Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) [ Time Frame: Baseline, Day 1 &15 of each treatment cycle up to 1 year on study ]
  10. Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index [ Time Frame: Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137449

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United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Lyon Cedex 08, France, 69373
Pfizer Investigational Site
Villejuif, France, 94805
Pfizer Investigational Site
Milano, Italy, 20133
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00137449     History of Changes
Other Study ID Numbers: A6181047
First Posted: August 29, 2005    Key Record Dates
Results First Posted: September 4, 2009
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action