Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00447005

Purpose

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.

Condition	Intervention	Phase
Carcinoma	Drug: Axitinib (AG-013736)	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

The incidence of all adverse events by type and grade, Abnormal laboratory changes(every 2 weeks) [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics (at single dosing, 1st ,15th and 29th day of multiple dosing following single dosing) [ Time Frame: End of study ] [ Designated as safety issue: No ]
Pharmacodynamic indices (4 times every 4 weeks and end of treatment) [ Time Frame: End of study ] [ Designated as safety issue: No ]
Anti-tumor activity (every 8 weeks until end of treatment) [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open: Experimental 5mg BID of AG-013736	Drug: Axitinib (AG-013736) AG-013736

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Central lung lesions involving major blood vessels
Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447005

Locations

Japan, Chiba
Pfizer Investigational Site
Kashiwa, Chiba, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061022
Study First Received:	March 12, 2007
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00447005
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Keywords provided by Pfizer:

Safety, PK, Biomarker

Study placed in the following topic categories:

Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009