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Completed Phase 2 Interventional Results available

Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT00064350

Public ClinicalTrials.gov record NCT00064350. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Study identification

NCT ID
NCT00064350
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
342 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 28, 2004 (Actual)
Primary completion
Mar 2011 (Actual)
Completion
Mar 2011 (Actual)
Last update posted
Jun 29, 2023

2004 – 2011

United States locations

U.S. sites
141
U.S. states
20
U.S. cities
106
Facility City State ZIP Site status
Stanford Comprehensive Cancer Center - Stanford Stanford California 94305 —
Aurora Presbyterian Hospital Aurora Colorado 80012 —
Boulder Community Hospital Boulder Colorado 80301-9019 —
Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado 80933 —
Porter Adventist Hospital Denver Colorado 80210 —
Presbyterian - St. Luke's Medical Center Denver Colorado 80218 —
St. Joseph Hospital Denver Colorado 80218 —
Rose Medical Center Denver Colorado 80220 —
CCOP - Colorado Cancer Research Program Denver Colorado 80224-2522 —
Swedish Medical Center Englewood Colorado 80110 —
Front Range Cancer Specialists Fort Collins Colorado 80528 —
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado 81502 —
Sky Ridge Medical Center Lone Tree Colorado 80124 —
Hope Cancer Care Center at Longmont United Hospital Longmont Colorado 80502 —
St. Mary - Corwin Regional Medical Center Pueblo Colorado 81004 —
North Suburban Medical Center Thornton Colorado 80229 —
Baptist Cancer Institute - Jacksonville Jacksonville Florida 32207 —
Rush-Copley Cancer Care Center Aurora Illinois 60507 —
St. Joseph Medical Center Bloomington Illinois 61701 —
Graham Hospital Canton Illinois 61520 —
Memorial Hospital Carthage Illinois 62321 —
Decatur Memorial Hospital Cancer Care Institute Decatur Illinois 62526 —
Alexian Brothers Radiation Oncology Elk Grove Village Illinois 60007 —
Eureka Community Hospital Eureka Illinois 61530 —
Galesburg Clinic, PC Galesburg Illinois 61401 —
Galesburg Cottage Hospital Galesburg Illinois 61401 —
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois 60426 —
Mason District Hospital Havana Illinois 62644 —
Hinsdale Hematology Oncology Associates Hinsdale Illinois 60521 —
Hopedale Medical Complex Hopedale Illinois 61747 —
Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois 60435 —
Kewanee Hospital Kewanee Illinois 61443 —
McDonough District Hospital Macomb Illinois 61455 —
BroMenn Regional Medical Center Normal Illinois 61761 —
Community Cancer Center Normal Illinois 61761 —
Community Hospital of Ottawa Ottawa Illinois 61350 —
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois 61350 —
Cancer Treatment Center at Pekin Hospital Pekin Illinois 61554 —
Proctor Hospital Peoria Illinois 61614 —
CCOP - Illinois Oncology Research Association Peoria Illinois 61615 —
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois 61615 —
Methodist Medical Center of Illinois Peoria Illinois 61636 —
OSF St. Francis Medical Center Peoria Illinois 61637 —
Illinois Valley Community Hospital Peru Illinois 61354 —
Perry Memorial Hospital Princeton Illinois 61356 —
Swedish-American Regional Cancer Center Rockford Illinois 61104-2315 —
St. Margaret's Hospital Spring Valley Illinois 61362 —
Carle Cancer Center at Carle Foundation Hospital Urbana Illinois 61801 —
CCOP - Carle Cancer Center Urbana Illinois 61801 —
Elkhart General Hospital Elkhart Indiana 46515 —
Howard Community Hospital Kokomo Indiana 46904 —
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana 46350 —
Clarian Arnett Cancer Care Lafayette Indiana 47904 —
Saint Anthony Memorial Health Centers Michigan City Indiana 46360 —
CCOP - Northern Indiana CR Consortium South Bend Indiana 46601 —
Memorial Hospital of South Bend South Bend Indiana 46601 —
Saint Joseph Regional Medical Center South Bend Indiana 46617 —
Cedar Rapids Oncology Associates Cedar Rapids Iowa 52403 —
Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa 51101 —
Mercy Medical Center - Sioux City Sioux City Iowa 51104 —
St. Luke's Regional Medical Center Sioux City Iowa 51104 —
Cancer Center of Kansas, PA - Chanute Chanute Kansas 66720 —
Cancer Center of Kansas, PA - Dodge City Dodge City Kansas 67801 —
Cancer Center of Kansas, PA - El Dorado El Dorado Kansas 67042 —
Cancer Center of Kansas, PA - Kingman Kingman Kansas 67068 —
Southwest Medical Center Liberal Kansas 67901 —
Cancer Center of Kansas, PA - Newton Newton Kansas 67114 —
Cancer Center of Kansas, PA - Parsons Parsons Kansas 67357 —
Cancer Center of Kansas, PA - Pratt Pratt Kansas 67124 —
Cancer Center of Kansas, PA - Salina Salina Kansas 67042 —
Cancer Center of Kansas, PA - Wellington Wellington Kansas 67152 —
Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas 67208 —
Cancer Center of Kansas, PA - Wichita Wichita Kansas 67214 —
CCOP - Wichita Wichita Kansas 67214 —
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas 67214 —
Cancer Center of Kansas, PA - Winfield Winfield Kansas 67156 —
Morton Hospital & Medical Center Taunton Massachusetts 02780 —
Saint Joseph Mercy Cancer Center Ann Arbor Michigan 48106-0995 —
CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan 48106 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Hurley Medical Center Flint Michigan 48503 —
Foote Hospital Jackson Michigan 49201 —
Borgess Medical Center Kalamazoo Michigan 49001 —
West Michigan Cancer Center Kalamazoo Michigan 49007-3731 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan 49085 —
Fairview Ridges Hospital Burnsville Minnesota 55337 —
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota 55433 —
Fairview Southdale Hospital Edina Minnesota 55435 —
Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota 55432 —
Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota 55109 —
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota 55407 —
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota 55422-2900 —
CCOP - Metro-Minnesota Saint Louis Park Minnesota 55416 —
Park Nicollet Cancer Center Saint Louis Park Minnesota 55416 —
United Hospital Saint Paul Minnesota 55102 —
Ridgeview Medical Center Waconia Minnesota 55387 —
Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota 55125 —
University Medical Center of Southern Nevada Las Vegas Nevada 89102 —
CCOP - Nevada Cancer Research Foundation Las Vegas Nevada 89106 —
Veterans Affairs Medical Center - East Orange East Orange New Jersey 07018-1095 —
Somerset Medical Center Somerville New Jersey 08876 —
Our Lady of Mercy Medical Center Comprehensive Cancer Center The Bronx New York 10466 —
Aultman Cancer Center at Aultman Hospital Canton Ohio 44710-1799 —
Christ Hospital Cancer Center Cincinnati Ohio 45219 —
Case Comprehensive Cancer Center Cleveland Ohio 44106-5065 —
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland Ohio 44109 —
St. Rita's Medical Center Lima Ohio 45801 —
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem Pennsylvania 18015 —
Bryn Mawr Hospital Bryn Mawr Pennsylvania 19010 —
Geisinger Medical Center Danville Pennsylvania 17822-0001 —
Easton Regional Cancer Center at Easton Hospital Easton Pennsylvania 18042 —
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850 —
Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne Pennsylvania 17043 —
Lewistown Hospital Lewistown Pennsylvania 17044 —
Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania 19301-1792 —
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania 19107 —
Geisinger Medical Group - Scenery Park State College Pennsylvania 16801 —
Mount Nittany Medical Center State College Pennsylvania 16803 —
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania 18711 —
CCOP - MainLine Health Wynnewood Pennsylvania 19096 —
Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania 19096 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
Medical X-Ray Center, PC Sioux Falls South Dakota 57105 —
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota 57117-5039 —
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville Tennessee 37901 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6838 —
UT Southwestern University Hospital - Zale Lipshy Dallas Texas 75235 —
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas 75390 —
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston West Virginia 25304 —
Fox Valley Hematology and Oncology - East Grant Street Appleton Wisconsin 54911-3496 —
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54301-3526 —
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin 54303 —
St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin 54303 —
St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54307-3508 —
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin 54601 —
Dean Medical Center - Madison Madison Wisconsin 53717 —
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin 53792-6164 —
Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin 54221-1450 —
Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin 54143 —
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00064350, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2023 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00064350 live on ClinicalTrials.gov.

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