Rollover Protocol for Prior SU011248 Protocols

This study has been completed.

First Received on November 25, 2008. Last Updated on January 9, 2012 History of Changes

Sponsor:	Pfizer
Information provided by (Responsible Party):	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
Solid Tumors	Drug: Sunitinib

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	313
Study Start Date:	March 2004
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sunitinib	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

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
ClinicalTrials.gov Identifier:	NCT00798889 History of Changes
Other Study ID Numbers:	A6181030
Study First Received:	November 25, 2008
Last Updated:	January 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Solid tumors

Additional relevant MeSH terms:

Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012