Rollover Protocol for Prior SU011248 Protocols

This study is currently recruiting participants.

Verified by Pfizer, November 2009

First Received: November 25, 2008 Last Updated: November 6, 2009 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00798889

Purpose

The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

Condition	Intervention	Phase
Solid Tumors	Drug: Sunitinib	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Continued access to SU011248 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Collection of long term AE profile [ Time Frame: Last patient last visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	325
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sunitinib: Experimental	Drug: Sunitinib Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol

Eligibility

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

Criteria

Inclusion Criteria:

Prior SU011248 Protocol.
Eligible to continue SU011248 treatment.

Exclusion Criteria:

Uncontrolled CNS metastasis.
Unfit to receive SU011248.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798889

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 49 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:	A6181030
Study First Received:	November 25, 2008
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00798889 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Solid tumors

Additional relevant MeSH terms:

Antineoplastic Agents
Sunitinib
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009