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

Phase 3
18 Years
Open (Enrolling)
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

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:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




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



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