AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT00111020

Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 320 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,567 participants
Where
320 sitesin 2 countries
Study dates
Jun 2005to Oct 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

320 sites in 2 countries.

308 sites in 2 countries

United States300 sites

  • Study site

    Albany, Georgia, 31701

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Allentown, Pennsylvania, 18105

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Ames, Iowa, 50010

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Arlington, Texas, 76012

  • Study site

    Armonk, New York, 10504

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78759

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Baltimore, Maryland, 21239

  • Study site

    Bangor, Maine, 4401

  • Study site

    Barberton, Ohio, 44203

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Bay Shore, New York, 11706

  • Study site

    Beech Grove, Indiana, 46107

  • Study site

    Belleville, New Jersey, 07109

  • Study site

    Bend, Oregon, 97701

  • Study site

    Bennington, Vermont, 5201

  • Study site

    Bessemer, Alabama, 35023

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Beverly, California, 90211

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Buffalo, New York, 14263

  • Study site

    Burlington, North Carolina, 27215

  • Study site

    Canton, Ohio, 44710

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cedar Rapids, Iowa, 52402

  • Study site

    Cedar Rapids, Iowa, 52403

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29403

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charleston, West Virginia, 25304

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Clarksville, Tennessee, 37043

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Clinton, Maryland, 20735

  • Study site

    Clinton Township, Michigan, 48038

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Columbia, South Carolina, 29210

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Concord, California, 94520

  • Study site

    Conway, Arkansas, 72034

  • Study site

    Cooperstown, New York, 13326

  • Study site

    Council Bluffs, Iowa, 51503

  • Study site

    Cranston, Rhode Island, 02920

  • Study site

    Cullman, Alabama, 35058

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75237

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dayton, Ohio, 45429

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Decatur, Illinois, 62526

  • Study site

    Denver, Colorado, 80210

  • Study site

    Denver, Colorado, 80218

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Duarte, California, 91010

  • Study site

    Dubuqe, Iowa, 52001

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Dunkirk, New York, 14048

  • Study site

    Dunmore, Pennsylvania, 18512

  • Study site

    East Orange, New Jersey, 7018

  • Study site

    East Stroudsburg, Pennsylvania, 18301

  • Study site

    East Syracuse, New York, 13057

  • Study site

    Evansville, Indiana, 47715

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fargo, North Dakota, 58108

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Fishers, Indiana, 46038

  • Study site

    Florence, South Carolina, 29501

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Fresh Meadows, New York, 11365

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Glendale, Arizona, 85304

  • Study site

    Glendale, California, 91206

  • Study site

    Glendale, Wisconsin, 53212

  • Study site

    Glens Falls, New York, 12801

  • Study site

    Glenwood Springs, Colorado, 81601

  • Study site

    Goshen, Indiana, 46526

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Green Bay, Wisconsin, 54301

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greenwich, Connecticut, 06830

  • Study site

    Hackensack, New Jersey, 7601

  • Study site

    Harrisburg, Pennsylvania, 17111

  • Study site

    Hartford, Connecticut, 06105

  • Study site

    Harvey, Illinois, 60426

  • Study site

    Hermitage, Pennsylvania, 16148

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Highland, California, 92346

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houma, Louisiana, 70360

  • Study site

    Houston, Texas, 77024

  • Study site

    Huntington, West Virginia, 25702

  • Study site

    Hutchinson, Kansas, 67502

  • Study site

    Indianapolis, Indiana, 46254

  • Study site

    Indianapolis, Indiana, 46256

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Jamaica, New York, 11432

  • Study site

    Jamaica Plain, Massachusetts, 2130

  • Study site

    Johnson City, New York, 13790

  • Study site

    Joliet, Illinois, 60432

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Kansas City, Missouri, 64118

  • Study site

    Kinston, North Carolina, 28501

  • Study site

    Kittanning, Pennsylvania, 16201

  • Study site

    Kokomo, Indiana, 46902

  • Study site

    La Jolla, California, 92037

  • Study site

    La Jolla, California, 92093

  • Study site

    La Porte, Indiana, 46350

  • Study site

    Lacey, Washington, 98503

  • Study site

    Lafayette, Colorado, 80026

  • Study site

    Lafayette, Louisiana, 70506

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Lancaster, Pennsylvania, 17604

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Latham, New York, 12110

  • Study site

    Lawrence, Kansas, 66044

  • Study site

    Lawton, Oklahoma, 73505

  • Study site

    Lebanon, New Hampshire, 03766

  • Study site

    Lemoyne, Pennsylvania, 17043

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Loma Linda, California, 92357

  • Study site

    Long Beach, California, 90813

  • Study site

    Long Branch, New Jersey, 07740

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Louisville, Kentucky, 40215

  • Study site

    Louisville, Kentucky, 40292

  • Study site

    Loveland, Colorado, 80538

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    Macon, Georgia, 31201

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Marquette, Michigan, 49855

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Mayfield Heights, Ohio, 44124

  • Study site

    Medford, Oregon, 97504

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Middletown, Connecticut, 06457

  • Study site

    Middletown, Ohio, 45042

  • Study site

    Midland, Texas, 79701

  • Study site

    Midwest City, Oklahoma, 73110

  • Study site

    Milford, Massachusetts, 01757

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Mineola, New York, 11501

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Missoula, Montana, 59807

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Monongahela, Pennsylvania, 15063

  • Study site

    Montclair, New Jersey, 07042

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    Mount Clemens, Michigan, 48043

  • Study site

    Mount Kisco, New York, 10549

  • Study site

    Muskegon, Michigan, 49443

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Britain, Connecticut, 06050

  • Study site

    New Brunswick, New Jersey, 08902

  • Study site

    New Haven, Connecticut, 6520

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10032

  • Study site

    Newark, New Jersey, 07112

  • Study site

    Newport Beach, California, 92663

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    North Charleston, South Carolina, 29406

  • Study site

    North Platte, Nebraska, 69103

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Ocala, Florida, 34474

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Ogden, Utah, 84403

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Olathe, Kansas, 66061

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68122

  • Study site

    Omaha, Nebraska, 68124

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32806

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Overland Park, Kansas, 66210

  • Study site

    Panama City, Florida, 32405

  • Study site

    Pensacola, Florida, 32501

  • Study site

    Pensacola, Florida, 32514

  • Study site

    Peoria, Illinois, 61615

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Phillipsburg, New Jersey, 08865

  • Study site

    Pine Bluff, Arkansas, 71603

  • Study site

    Pollocksville, North Carolina, 28573

  • Study site

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Portsmouth, New Hampshire, 03801

  • Study site

    Pottsville, Pennsylvania, 17901

  • Study site

    Poughkeepsie, New York, 12601

  • Study site

    Quincy, Massachusetts, 02169

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Richmond, Virginia, 23229

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rochester, New York, 14642

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Sacramento, California, 95823

  • Study site

    Saint Joseph, Missouri, 64507

  • Study site

    Saint Louis Park, Minnesota, 55416

  • Study site

    Saint Louis Park, Minnesota, 55426

  • Study site

    Salinas, California, 93901

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    San Antonio, Texas, 78212

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78245

  • Study site

    San Diego, California, 92120

  • Study site

    San Francisco, California, 94115

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Scarborough, Maine, 04074

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Seattle, Washington, 98101

  • Study site

    Seattle, Washington, 98104

  • Study site

    Setauket, New York, 11733

  • Study site

    Shreveport, Louisiana, 71105

  • Study site

    Sioux City, Iowa, 51101

  • Study site

    Sioux Falls, South Dakota, 57104

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Southington, Connecticut, 06489

  • Study site

    Springdale, Arkansas, 72764

  • Study site

    Springfield, Illinois, 62701

  • Study site

    Springfield, Massachusetts, 1104

  • Study site

    Springfield, Massachusetts, 1107

  • Study site

    Springfield, Missouri, 65804

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63136

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. Petersburg, Florida, 33705

  • Study site

    Stamford, Connecticut, 06902

  • Study site

    Stanford, California, 94305

  • Study site

    State College, Pennsylvania, 16803

  • Study site

    Stony Brook, New York, 11794

  • Study site

    Stuart, Florida, 34994

  • Study site

    Summit, New Jersey, 07901

  • Study site

    Sunnyvale, California, 94086

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tamc, Hawaii, 96859

  • Study site

    Tampa, Florida, 33607

  • Study site

    Temple, Texas, 76502

  • Study site

    The Bronx, New York, 10466

  • Study site

    The Bronx, New York, 10469

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Tyler, Texas, 75701

  • Study site

    Tyler, Texas, 75702

  • Study site

    Urbana, Illinois, 61801

Other trials in United States

Canada8 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H2W 1S6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

Being tested
Sorafenib (Nexavar, BAY43-9006)
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC

Study groups in NCT00111020
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety parameters

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

Secondary outcomes (1)

  1. Limited radiological evaluations

    Measured: At baseline, than every 8 weeks after start of sorafenib

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJun 2007
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111020
Sponsor's protocol ID
11868
Status last verified
Aug 2014
First submitted
16 May 2005
Last updated
6 Aug 2014
Results posted
No
Data monitoring committee
No
Expanded access
Available

Publications

  • Stadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80. doi: 10.1002/cncr.24864.

    PubMed 20082451

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 320 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety parameters (time frame: From signing consent to 30 days after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in