A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Breast Cancer, Advanced Breast Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Renal Cell Cancer, Non-Small Cell Lung Cancer, Thyroid Cancer, Advanced/Metastatic Non-Small Cell Lung Cancer, Advanced Gastric Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma, Pancreatic Islet Cell Carcinoma, Pancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Drug: sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have ended treatment from one of the following sunitinib 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. Exclusion Criteria: See inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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. | Drug: sunitinib<br>* sunitinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities. | From first day of treatment on the current study up to 28 days post the last dose of study treatment | 
| Number of Participants With Treatment-emergent AEs (Treatment-Related) | Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities. | From first day of treatment on the current study up to 28 days post the last dose of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Potentially other tumor types in the future