Overview

This trial is active, not recruiting.

Conditions metastatic breast cancer [f], 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
Treatment sunitinib
Targets VEGF, FLT-3, KIT, PDGF
Sponsor Pfizer
Start date July 2007
End date September 2014
Trial size 300 participants
Trial identifier NCT00428220, A6181114

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
sunitinib
sunitinib

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Pfizer.