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


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

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Trial Information

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


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.

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

Outcome Time Frame:

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:

A4061051

NCT ID:

NCT00920816

Start Date:

August 2009

Completion Date:

July 2014

Related Keywords:

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

Name

Location

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 SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
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 SiteOmaha, Nebraska  68198
Pfizer Investigational SiteLivingston, New Jersey  07039