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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Safety and tolerability of axitinib: number of patients with metastatic renal cell cancer with incidence of drug related adverse events. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Duration of Response in Each Arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Kidney Specific Symptoms tested by Functional Assessment of Cancer Therapy Kidney Symptom Index [FKSI] and Health Status European Quality of Life Scale [EQ-5D] [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	723
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2015
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

Show 267 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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. Epub 2011 Nov 4.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00678392 History of Changes
Other Study ID Numbers:	A4061032, AXIS TRIAL
Study First Received:	May 12, 2008
Last Updated:	January 4, 2012
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:

Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012