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Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
First received: June 11, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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.


Condition Intervention Phase
Kidney Neoplasms
 Drug: Axitinib (AG-013736)
Drug: Sorafenib
 Phase 3

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) For the Treatment of Metastatic Renal Cell Cancer

Resource links provided by NLM:

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 on Axitinib [ 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 and Health Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2012 (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 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.
  • Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

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: NCT00920816

  Show 119 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
ClinicalTrials.gov Identifier: NCT00920816     History of Changes
Other Study ID Numbers: A4061051
Study First Received: June 11, 2009
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Axitinib in First & 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 May 23, 2013