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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137449
• Other study ID #: A6181047
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: September 9, 2009
• Start date: September 2005
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Lyon Cedex 08
France	Pfizer Investigational Site	Villejuif
Italy	Pfizer Investigational Site	Milano
United States	Pfizer Investigational Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Benefit Response (CBR) According to RECIST		Planned duration on this protocol of up to 1 year	No
Secondary	Number of Participants by Best Confirmed Response Category According to RECIST		Planned duration on this protocol of up to 1 year	No
Secondary	Number of Participants With Overall Confirmed Objective Disease Response (ORR)		Planned duration on this protocol of up to 1 year	No
Secondary	Duration of Stable Disease		Planned duration on this protocol of up to 1 year	No
Secondary	Progression-free Survival (PFS)		Planned duration on this protocol of up to 1 year	No
Secondary	Time to Tumor Progression (TTP)		Planned duration on this protocol of up to 1 year	No
Secondary	Duration of Tumor Response (DR) [Descriptive Statistics]		Planned duration on this protocol of up to 1 year	No
Secondary	Overall Survival (OS) and One-year Survival [Descriptive Statistics]		Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.	No
Secondary	Score of FACIT-Fatigue Scale		Baseline, Day 1 & 15 of each treatment cycle	No
Secondary	Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)		Baseline, Day 1 &15 of each treatment cycle up to 1 year on study	No
Secondary	Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index		Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study	No

External Links

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