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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137449
First received: August 26, 2005
Last updated: September 9, 2009
Last verified: September 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014