A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
NCT00443534
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.
- Severe acute or chronic medical or psychiatric condition, or laboratory abnormality
that may increase the risk associated with study participation or study drug
administration, or may interfere with the interpretation of study results, and in the
judgment of the investigator would make the patient inappropriate for entry into this
study.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol. | |||
| Official Title ICMJE | A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol. | |||
| Brief Summary | This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended. | |||
| 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 | Neoplasms | |||
| Intervention ICMJE | Drug: SU011248
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol Other Name: Sutent/Sunitinib | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Drug: SU011248 | |||
| 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 | 123 | |||
| Original Enrollment ICMJE | 500 | |||
| 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 | Canada, France, Germany, Italy, Spain, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00443534 | |||
| Other Study ID Numbers ICMJE | A6181078 | |||
| 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 | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||