Spots Global Cancer Trial Database for BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
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Trial Identification
Brief Title: BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
Official Title: A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.
Study ID: NCT00117637
Conditions
Study Description
Brief Summary: The purpose of the study is to: * Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a * Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression * Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a * Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage * Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer * Find out the level of BAY43-9006 in the blood once per month and any changes in this level * Find out whether BAY43-9006 effects are associated with specific biomarkers
Detailed Description: Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Sacramento, California, United States
, Aurora, Colorado, United States
, Chicago, Illinois, United States
, Frederick, Maryland, United States
, Las Vegas, Nevada, United States
, Cleveland, Ohio, United States
, Portland, Oregon, United States
, Dallas, Texas, United States
, Seattle, Washington, United States
, Bordeaux, , France
, Lille Cedex, , France
, Lyon Cedex, , France
, Marseille, , France
, Nantes, , France
, Paris Cedex 15, , France
, Toulouse, , France
, Villejuif, , France
, Ulm, Baden-Württemberg, Germany
, München, Bayern, Germany
, Frankfurt, Hessen, Germany
, Düsseldorf, Nordrhein-Westfalen, Germany
, Mainz, Rheinland-Pfalz, Germany
, Berlin, , Germany
, Hamburg, , Germany
, Gdansk, , Poland
, Krakow, , Poland
, Poznan, , Poland
, Szczecin, , Poland
, Warszawa, , Poland
, Warszawa, , Poland
, Wroclaw, , Poland
, Kazan, , Russian Federation
, Kirov, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, St. Petersburg, , Russian Federation
, Donetsk, , Ukraine
, Kharkiv, , Ukraine
, Kiev, , Ukraine
, Lviv, , Ukraine
, Sutton, Surrey, United Kingdom
, London, , United Kingdom
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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