Last updated date
ABOUT THIS STUDY
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
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Solid Tumors
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Prior SU011248 Protocol.
- Eligible to continue SU011248 treatment.
Exclusion Criteria
Show details
- Uncontrolled CNS metastasis.
- Unfit to receive SU011248.
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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 | 314 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |