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Rollover Protocol for Prior SU011248 Protocols

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798889
First Posted: November 26, 2008
Last Update Posted: January 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Enrollment: 314
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00798889     History of Changes
Obsolete Identifiers: NCT00569725
Other Study ID Numbers: A6181030
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: December 13, 2012
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


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