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

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