Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
NCT00447005
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- Patients histologically or cytologically diagnosed with advanced malignant solid tumors
- Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
- Central lung lesions involving major blood vessels
- Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors | |||
Official Title ICMJE | A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors | |||
Brief Summary | To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma | |||
Intervention ICMJE | Drug: Axitinib (AG-013736)
AG-013736 5mg twice daily [BID] | |||
Study Arms ICMJE | Experimental: Open
Intervention: Drug: Axitinib (AG-013736) | |||
Publications * | Mukohara T, Nakajima H, Mukai H, Nagai S, Itoh K, Umeyama Y, Hashimoto J, Minami H. Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients. Cancer Sci. 2010 Apr;101(4):963-8. doi: 10.1111/j.1349-7006.2009.01465.x. Epub 2009 Dec 9. | |||
* 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 | 12 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 75 Years (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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00447005 | |||
Other Study ID Numbers ICMJE | A4061022 | |||
Has Data Monitoring Committee | Yes | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |