Rollover Protocol for Prior SU011248 Protocols
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00798889
First received: November 25, 2008
Last updated: December 13, 2012
Last verified: December 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798889
Show 59 Study Locations
Show 59 Study LocationsSponsors 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 June 17, 2013