Clinical trial NCT00137449: Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Number of Participants With Clinical Benefit Response (CBR) According to RECIST
timeFrame: Planned duration on this protocol of up to 1 year
Secondary outcomes:
measure: Number of Participants by Best Confirmed Response Category According to RECIST
timeFrame: Planned duration on this protocol of up to 1 year
measure: Number of Participants With Overall Confirmed Objective Disease Response (ORR)
timeFrame: Planned duration on this protocol of up to 1 year
measure: Duration of Stable Disease
timeFrame: Planned duration on this protocol of up to 1 year
measure: Progression-free Survival (PFS)
timeFrame: Planned duration on this protocol of up to 1 year
measure: Time to Tumor Progression (TTP)
timeFrame: Planned duration on this protocol of up to 1 year
measure: Duration of Tumor Response (DR) [Descriptive Statistics]
timeFrame: Planned duration on this protocol of up to 1 year
measure: Overall Survival (OS) and One-year Survival [Descriptive Statistics]
timeFrame: Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.
measure: Score of FACIT-Fatigue Scale
timeFrame: Baseline, Day 1 & 15 of each treatment cycle
measure: Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)
timeFrame: Baseline, Day 1 &15 of each treatment cycle up to 1 year on study
measure: Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index
timeFrame: Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Lyon Cedex 08
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: