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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Axitinib

U.S. FDA Resources

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:	September 2009
Primary Completion Date:	February 2009 (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

Locations

United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10466
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061023
Study First Received:	January 23, 2006
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00282048 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009