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Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma


Phase 3
15 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma


Inclusion Criteria:



- Patients with advanced (unresectable, recurrent or metastatic) RCC

- Patients reasonably likely to benefit from treatment with sorafenib as a single agent
therapy

- Patients with an ECOG performance status of 0-2

- Patients who will not require other systemic anticancer therapy (except for
bisphosphonates) while taking sorafenib

- Patients with vascular diseases such as wet macular degeneration, vasculitis, or new
peptic ulcer, may be enrolled but require close monitoring in accordance with
established medical practice

Exclusion Criteria:

- Patients who are currently enrolled in, are eligible for, or have access to, any
other sorafenib clinical trial

- Patients who have participated in any other sorafenib trial

- Patients who have had prior therapy with investigational agent(s) within the last
four weeks prior to study entry

- Life expectancy of less than two months

- Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0

- Patients with active coronary artery disease or ischemia

- Patients with Child-Pugh class C hepatic impairment

- Patients with severe renal impairment or who require dialysis

- Patients with active uncontrolled hypertension

- Patients with recent or active bleeding diathesis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety parameters

Outcome Time Frame:

From signing consent to 30 days after last dose of study drug

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

11868

NCT ID:

NCT00111020

Start Date:

June 2005

Completion Date:

October 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Anchorage, Alaska  
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Lebanon, New Hampshire  
Tulsa, Oklahoma  
Honolulu, Hawaii  96813
Charleston, West Virginia  25304
Providence, Rhode Island  02908
Las Vegas, Nevada  89109
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814