Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer


Tracking Information

Start Date  ICMJEJuly 2008
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2008)		Progression-Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00678392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 12, 2008)
  • 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAxitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Official Title  ICMJEAxitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEKidney Neoplasms
Intervention  ICMJE
  • Drug: Axitinib (AG-013736)
    axitinib will be given at a starting dose of 5 mg BID with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg BID with continuous dosing
Study Arms / Comparison Groups
  • A: Experimental
    Intervention: Drug: Axitinib (AG-013736)
  • B: Active Comparator
    Intervention: Drug: Sorafenib

Recruitment Information

Estimated Enrollment  ICMJE650
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service1-877-369-9753PfizerCancerTrials@emergingmed.com
Location Countries  ICMJEUnited States,   Australia,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Greece,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00678392
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA4061032, AXIS TRIAL
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer