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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00137449 |
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Date of registration:
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26/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
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Scientific title:
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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 |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00137449 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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France
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Italy
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastrointestinal Stromal Tumors
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Intervention(s)
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Drug: SU011248
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Primary Outcome(s)
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Number of Participants With Clinical Benefit Response (CBR) According to RECIST
[Time Frame: Planned duration on this protocol of up to 1 year]
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Secondary Outcome(s)
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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.]
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Number of Participants With Overall Confirmed Objective Disease Response (ORR)
[Time Frame: Planned duration on this protocol of up to 1 year]
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Number of Participants by Best Confirmed Response Category According to RECIST
[Time Frame: Planned duration on this protocol of up to 1 year]
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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]
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Duration of Stable Disease
[Time Frame: Planned duration on this protocol of up to 1 year]
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Score of FACIT-Fatigue Scale
[Time Frame: Baseline, Day 1 & 15 of each treatment cycle]
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Duration of Tumor Response (DR) [Descriptive Statistics]
[Time Frame: Planned duration on this protocol of up to 1 year]
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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]
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Progression-free Survival (PFS)
[Time Frame: Planned duration on this protocol of up to 1 year]
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Time to Tumor Progression (TTP)
[Time Frame: Planned duration on this protocol of up to 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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