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

NCT00678392 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 723

Last updated 2019-01-09

Study results available
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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.

Conditions

  • Kidney Neoplasms

Interventions

DRUG

Axitinib (AG-013736)

axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing

DRUG

Sorafenib

sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-03
Primary Completion
2010-08-31
Completion
2016-02-25

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Greece
  • India
  • Ireland
  • Italy
  • Japan
  • Poland
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678392 on ClinicalTrials.gov