Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer - Full Text View

Purpose

To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).

Condition	Intervention	Phase
Kidney Neoplasms Carcinoma, Renal Cell	Drug: AG-013736 (axitinib)	Phase II

MedlinePlus related topics:

Cancer Kidney Cancer

Drug Information available for:

Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase 2 Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Measured by overall objective response rate, CR and PR, by RECIST. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Explore effects of treatment on patient reported outcomes [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Cancer related symptoms (FKSI) [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Explore PK correlates with response or adverse events. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
Safety profile of AG-013736 [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	March 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity	Drug: AG-013736 (axitinib) AG-013736 5 mg bid continuous dosing in 28 day cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

RCC with metastases and nephrectomy
failure of prior sorafenib-based therapy
at least 1 target lesion that has not been irradiated
adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.

Exclusion Criteria:

Gastrointestinal abnormalities
current use or inability to avoid chronic antacid therapy
current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
active seizure disorder or evidence of brain metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282048

Contacts


Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


United States, Illinois
	Pfizer Investigational Site	Recruiting
	Chicago, Illinois, United States, 60637

United States, New York
	Pfizer Investigational Site	Active, not recruiting
	Bronx, New York, United States, 10466

United States, Ohio
	Pfizer Investigational Site	Active, not recruiting
	Cleveland, Ohio, United States, 44195

United States, Pennsylvania
	Pfizer Investigational Site	Active, not recruiting
	Philadelphia, Pennsylvania, United States, 19111-2497

United States, Wisconsin
	Pfizer Investigational Site	Active, not recruiting
	Madison, Wisconsin, United States, 53792

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:	A4061023
First Received:	January 23, 2006
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00282048
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Urogenital Neoplasms

Renal cancer

Kidney Diseases

Kidney cancer

Urologic Neoplasms

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00282048