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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Kidney Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

Outcome Time Frame:

Week 6, Week 12, every 8 weeks thereafter up to 3 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061032

NCT ID:

NCT00678392

Start Date:

September 2008

Completion Date:

July 2015

Related Keywords:

  • Kidney Neoplasms
  • Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteLewistown, Idaho  83501