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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Sorafenib Axitinib Sorafenib tosylate

U.S. FDA Resources

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 or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
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 than 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 310 Study Locations

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:	A4061032, AXIS TRIAL
Study First Received:	May 12, 2008
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00678392 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Kidney Diseases
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009