A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.
Metastatic Breast Cancer
Advanced Breast Cancer
Advanced Gastric Cancer
Advanced/Metastatic Non-small Cell Lung Cancer
Gastrointestinal Stromal Tumor
Metastatic Castration-resistant Prostate Cancer
Metastatic Renal Cell Cancer
Non Small Cell Lung Cancer
Pancreatic Islet Cell Carcinoma
Pancreatic Neuroendocrine Tumor
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Sunitinib Malate (SU011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment.|
- The objective of the study is to assess long term safety and tolerability of patients enrolling from prior Sutent clinical studies. Duration of clinical benefit will be assessed for patients enrolling from protocol A6181111; PNET. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Sunitinib will be administered in a continuous daily dose (oral, once per day). Starting dose will be 37.5 mg daily unless the patient was on a different dose (25 mg or 50 mg daily) on the previous trial. In that case, they will begin treatment on this study at the same dose used at the end of the previous study.
The protocol now allows for patients on dosing regimens other than only continuous dosing (e.g. 4/2, etc.) to be enrolled if eligible.
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|