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Rollover Protocol for Prior SU011248 Protocols

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ClinicalTrials.gov Identifier: NCT00798889
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment
Solid Tumors Drug: Sunitinib

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol
Study Start Date : March 2004
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Duration of Treatment [ Time Frame: Baseline up to Day 28 after last dose of study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior SU011248 Protocol.
  • Eligible to continue SU011248 treatment.

Exclusion Criteria:

  • Uncontrolled CNS metastasis.
  • Unfit to receive SU011248.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798889


  Show 59 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00798889     History of Changes
Obsolete Identifiers: NCT00569725
Other Study ID Numbers: A6181030
First Posted: November 26, 2008    Key Record Dates
Results First Posted: January 21, 2013
Last Update Posted: January 21, 2013
Last Verified: December 2012

Keywords provided by Pfizer:
Solid tumors

Additional relevant MeSH terms:
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors