Rollover Protocol for Prior SU011248 Protocols

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00798889
First received: November 25, 2008
Last updated: December 13, 2012
Last verified: December 2012
  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:


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 ] [ Designated as safety issue: Yes ]

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

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
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, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00798889     History of Changes
Other Study ID Numbers: A6181030
Study First Received: November 25, 2008
Results First Received: December 13, 2012
Last Updated: December 13, 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 August 18, 2014