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

Pfizer

Status: Completed

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

Treatments: Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00428220

2006-006538-16 (EudraCT Number)

A6181114

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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223 participants in 1 patient group

A

Experimental group

Description:

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.

Treatment:

Drug: sunitinib