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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Boston, Massachusetts, 02115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Stromal Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00137449
Pfizer
Completed
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

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Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor
To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
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.
Experimental: A
Intervention: Drug: SU011248
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2008
April 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United States
 
 
NCT00137449
A6181047
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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