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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 25, 2008 | ||||||||
| Last Updated Date | October 8, 2009 | ||||||||
| Start Date ICMJE | March 2004 | ||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Continued access to SU011248 [ Time Frame: Duration of study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00798889 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Collection of long term AE profile [ Time Frame: Last patient last visit ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| 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 |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment | ||||||||
| Condition ICMJE | Solid Tumors | ||||||||
| Intervention ICMJE | Drug: Sunitinib | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 325 | ||||||||
| Estimated Completion Date | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Australia, Canada, France, Greece, Italy, Netherlands, Singapore, Sweden, Switzerland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00798889 | ||||||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||||||
| Study ID Numbers ICMJE | A6181030 | ||||||||
| Study Sponsor ICMJE | Pfizer | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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