Rollover Protocol for Prior SU011248 Protocols

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NCT00798889

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233-2115, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Prior SU011248 Protocol.

- Eligible to continue SU011248 treatment.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Uncontrolled CNS metastasis.


- Unfit to receive SU011248.

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  6. San Francisco, California
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  14. Ann Arbor, Michigan
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  24. Durham, North Carolina
  25. Cleveland, Ohio
  26. Philadelphia, Pennsylvania
  27. Myrtle Beach, South Carolina
  28. Franklin, Tennessee
  29. Gallatin, Tennessee
  30. Hermitage, Tennessee
  31. Lebanon, Tennessee
  32. Murfreesboro, Tennessee
  33. Nashville, Tennessee
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Advanced Information
Descriptive Information
Brief Title  ICMJE Rollover Protocol for Prior SU011248 Protocols
Official Title  ICMJE A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Sunitinib
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2012)		314
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)		325
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled CNS metastasis.
  • Unfit to receive SU011248.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Greece,   Italy,   Netherlands,   Singapore,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798889
Other Study ID Numbers  ICMJE A6181030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP