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| Descriptive Information Fields | |||||||||
| Brief Title † | A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors | ||||||||
| Official Title † | A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, Sutent) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors | ||||||||
| Brief Summary | This study will randomize patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who are randomized to sunitinib will receive 37.5 mg of sunitinib daily, those randomized to placebo will receive a tablet that looks similar but has no active drug. Neither the patient or the doctor will know whether the patient is receiving sunitinib or placebo. Patients will be followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Progression free survival [ Time Frame: duration of study until PD, or death ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Time to response [ Time Frame: duration of study ] [ Designated as safety issue: No ] Safety and tolerability [ Time Frame: duration of study ] [ Designated as safety issue: Yes ] Patient-reported outcomes [ Time Frame: duration of study ] [ Designated as safety issue: No ] Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ] Tumor response [ Time Frame: duration of study ] [ Designated as safety issue: No ] Duration of response [ Time Frame: duration of study ] [ Designated as safety issue: No ] |
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| Condition † | Carcinoma, Islet Cell | ||||||||
| Intervention † | Drug: sunitinib malate Drug: Placebo |
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| MEDLINE PMIDs | |||||||||
| Links | To obtain contact information for a study center near you, click here.  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 340 | ||||||||
| Start Date † | March 2007 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Australia, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00428597 | ||||||||
| Organization ID | A6181111 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Pfizer | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Pfizer | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | January 29, 2007 | ||||||||
| Last Updated Date | November 21, 2008 | ||||||||
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