Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137449
First received: August 26, 2005
Last updated: September 9, 2009
Last verified: September 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumors |
Drug: SU011248 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Clinical Benefit Response (CBR) According to RECIST [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants by Best Confirmed Response Category According to RECIST [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- Number of Participants With Overall Confirmed Objective Disease Response (ORR) [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- Duration of Stable Disease [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- Progression-free Survival (PFS) [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- Time to Tumor Progression (TTP) [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- Duration of Tumor Response (DR) [Descriptive Statistics] [ Time Frame: Planned duration on this protocol of up to 1 year ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Score of FACIT-Fatigue Scale [ Time Frame: Baseline, Day 1 & 15 of each treatment cycle ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137449
Locations
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| France | |
| Pfizer Investigational Site | |
| Lyon Cedex 08, France, 69373 | |
| Pfizer Investigational Site | |
| Villejuif, France, 94805 | |
| Italy | |
| Pfizer Investigational Site | |
| Milano, Italy, 20133 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00137449 History of Changes |
| Other Study ID Numbers: | A6181047 |
| Study First Received: | August 26, 2005 |
| Results First Received: | April 10, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013