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

Not Applicable

Completed

• Conditions: Pancreatic Islet Cell Carcinoma; Advanced/Metastatic Non-Small Cell Lung Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Thyroid Cancer; Hepatocellular Carcinoma; Metastatic Castration Resistant Prostate Cancer; Metastatic Renal Cell Cancer; Non-Small Cell Lung Cancer; Advanced Gastric Cancer
• Interventions: Drug: sunitinib

• Registration Number: NCT00428220
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-07
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Results First Submitted: 2015-07-26
• Results First Submitted QC: 2015-10-07
• Results First Posted: 2015-11-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	sunitinib	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent AEs (Treatment-Related)	From first day of treatment on the current study up to 28 days post the last dose of study treatment	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.
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)	From first day of treatment on the current study up to 28 days post the last dose of study treatment	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.

Trial Locations

Locations (112)

Emory University, Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Investigational Drug Service; 🇺🇸 Atlanta, Georgia, United States

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Siteman Cancer Center-West County; 🇺🇸 Creve Coeur, Missouri, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Washington University School of Medicine, Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Siteman Cancer Center; 🇺🇸 Saint Peters, Missouri, United States

Comprehensive Cancer Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

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