A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

This study is currently recruiting participants.

Verified by Pfizer, January 2009

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00443534

Purpose

This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Condition	Intervention	Phase
Neoplasms	Drug: SU011248	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess the type, incidence, timing, seriousness and relatedness of adverse events and laboratory abnormalities [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	May 2006
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SU011248 Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol

Eligibility

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

Criteria

Inclusion Criteria:

Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443534

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 52 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181078
Study First Received:	March 2, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00443534
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sunitinib

Additional relevant MeSH terms:

Neoplasms
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009