A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00428220

Purpose

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: A6181107, A6181108, A6181110, A6181111, or A6181112.

Condition	Intervention	Phase
Carcinoma, Renal Cell Breast Neoplasms Carcinoma, Islet Cell Gastrointestinal Stromal Tumors	Drug: sunitinib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The objective of the study is to assess long term safety, tolerability, and duration of clinical benefit, in patients who have completed a previous sunitinib clinical trial. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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.	Drug: sunitinib sunitinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have ended treatment from one of the following sunitinib studies: A6181107, A6181108, A6181110, A6181111, or A6181112.

Exclusion Criteria:

See inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428220

Show 88 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181114
Study First Received:	January 26, 2007
Last Updated:	February 6, 2010
ClinicalTrials.gov Identifier:	NCT00428220 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Sunitinib
Kidney Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Breast Diseases

Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Skin Diseases
Growth Substances
Carcinoma, Islet Cell
Breast Neoplasms
Endocrine System Diseases
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Carcinoma, Renal Cell
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010