Axitinib (Ag 013736) As Second Line Therapy For Metastatic Renal Cell Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00678392

Purpose

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

Condition	Intervention	Phase
Kidney Neoplasms	Drug: Axitinib (AG-013736) Drug: Sorafenib	Phase III

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Sorafenib Sorafenib tosylate Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Axitinib (Ag 013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate Safety and Tolerability on Axitinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Estimate the Duration of Response in Each Arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare the Kidney Specific Symptoms and Health Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	540
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Axitinib (AG-013736) axitinib will be given at a starting dose of 5 mg BID with continuous dosing
B: Active Comparator	Drug: Sorafenib sorafenib will be given at a dose of 400 mg BID with continuous dosing

Eligibility

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

Criteria

Inclusion Criteria:

Histologically documented metastatic renal cell cancer with a component of clear cell histology.
Evidence of measurable disease
Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678392

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

Show 123 Study Locations

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:	A4061032, AXIS TRIAL
Study First Received:	May 12, 2008
Last Updated:	December 20, 2008
ClinicalTrials.gov Identifier:	NCT00678392
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009