Trial Information
A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic
islet cell tumor.
- Evidence of unidimensionally measurable disease as per Response Evaluation Criteria
in Solid Tumors (RECIST).
- ECOG performance status 0 or 1
Exclusion Criteria:
- Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell
carcinoma, or any other second malignancy within the last 5 years except for
adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma
of the cervix uteri.
- Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic
inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is
permitted.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Radiographic objective disease response
Outcome Time Frame:
From screening until disease progression or discontinuation of study
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
RTKC-0511-015
NCT ID:
NCT00056693
Start Date:
April 2003
Completion Date:
September 2006
Related Keywords:
- Neuroendocrine Tumors
- Neuroendocrine tumor, advanced disease, sunitinib, Phase 2
- Neuroendocrine Tumors
Name | Location |
Pfizer Investigational Site |
Birmingham, Alabama 35205 |
Pfizer Investigational Site |
Blendora, California 91740 |
Pfizer Investigational Site |
Springfield, Illinois 62701-1014 |
Pfizer Investigational Site |
North Adams, Massachusetts 01247 |
Pfizer Investigational Site |
Columbia, Missouri 65201 |
Pfizer Investigational Site |
Kingston, Pennsylvania 18704-5535 |