A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.
NCT00078000
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- Anthracycline and taxane-refractory or intolerant metastatic breast cancer
- Female
- Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic
disease setting beyond those containing anthracyclines/taxanes.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies. | |||
Official Title ICMJE | A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer | |||
Brief Summary | Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE | Drug: SU011248 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Keyvanjah K, DePrimo SE, Harmon CS, Huang X, Kern KA, Carley W. Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib. J Transl Med. 2012 Aug 16;10:165. doi: 10.1186/1479-5876-10-165. | |||
* 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 | 64 | |||
Original Enrollment ICMJE | 63 | |||
Actual Study Completion Date ICMJE | November 2005 | |||
Primary Completion Date | Not Provided | |||
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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00078000 | |||
Other Study ID Numbers ICMJE | A6181002 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |