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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00080340
Other study ID # TLK286.3020
Secondary ID
Status Completed
Phase Phase 3
First received March 26, 2004
Last updated January 10, 2008
Est. completion date May 2005

Study information

Verified date March 2006
Source Telik
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.


Recruitment information / eligibility

Status Completed
Enrollment 520
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of non-small cell lung cancer

- Non-small cell lung cancer that is not curable with surgery, radiation, or combined modality chemoradiation

- Failed two prior chemotherapy regimens which must have included platinum

- Measurable disease

Exclusion Criteria:

- Treatment with more than two prior chemotherapy regimens

- History of bone marrow transplantation or stem cell support

- Pregnant or lactating women

- Known history of prior gefitinib therapy

- Known history of prior TLK286 therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
TLK286 (Telcyta) HCl for Injection

gefitinib (Iressa)


Locations

Country Name City State
Argentina Policlinica Privada Instituto de Medicina Nuclear Bahia Blanca Buenos Aires
Argentina Complejo Medico de la Policia Federal Argentina "Churruca-Visca" - Servicio de Oncologia Buenos Aires
Argentina Hospital General de Agudos "Carlos G. Durand" - Servicio de Oncologia Buenos Aires
Argentina Instituto Alexander flaming Buenos Aires
Argentina Hospital Alvarez Capital Federal Buenos Aires
Argentina Hospital Britanico de Buenos Aires Capital Federal Buenos Aires
Argentina Hospital de Oncologia Maria Curie Capital Federal Buenos Aires
Argentina Hospital Donacion F. Santojanni Capital Federal Buenos Aires
Argentina Hospital Privado de Comunidad Cordoba Mar del Plata
Argentina Sociedad de Beneficencia Hospital Italiano Cordoba
Argentina Hospital Universitario Austral - Servicio de Oncologia Pilar Buenos Aires
Argentina Instituto CAICI Rosario
Argentina H.I.G.A. Eva Peron San Martin
Australia Albury Base Hospital Albury New South Wales
Australia West Albury Barker's Pharmacy Albury New South Wales
Australia Bankstown Lidcombe Hospital - Department of Medical Oncology Bankstown
Australia Flinders Medical Centre Bedford Park South Australia
Australia St. Vincent's Hospital Fitzroy Victoria
Australia Royal Hobart Hospital Hobart
Australia Sir Charles Gairdner Hospital Nedlands
Australia Department Of Oncology South Brisbane Queensland
Australia Royal North Shore Hospital-Medical Oncology Dept. St. Leonards
Australia Department of Medical Oncology-Newcastle Mater Misericordiae Hospital Waratah New South Wales
Australia Pharmatel Fresenius Kabi Pty Ltd. West Melbourne Victoria
Australia Border Medical Oncology - Murray Valley Private Hospital Wodonga
Australia Murray Valley Private Hospital Wodonga Victoria
Australia Clinical Trials Centre - Wollongong Hospital Wollongong
Brazil Hospital Vera Cruz Belo Horizonte MG
Brazil Hospital das Clinicas da UFPR Curitiba PR
Brazil Pro Onco Centro de Tratamento Oncologico S/C Ltda. Curitiba PR
Brazil Instituto do Cancer do Ceara Fortaleza CE
Brazil Associacao de Combate ao cancer de Goias - Hospital Goiania GO
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital Sao Lucas-PUCRS Porto Alegre RS
Brazil Nucleo de Oncologia da Bahia Salvador BA
Brazil Santo Andre Diagnostico e Tratamento Ltda Santo Andre SP
Brazil Santo Andre Diagnosticos e Tratamentos Santo Andre SP
Brazil Santo Andre Diagnosticos e Tratamentos Ltda. Santo Andre SP
Brazil Complexo Hospitalar Heliopolis Sao Paulo SP
Brazil Conjunto Hospitalar de Sorocaba Sao Paulo SP
Brazil Fundacao Pio XII - Hospital do Cancer de Barretos Sao Paulo SP
Brazil Hospital das Clinicas - Universidade de Sao Paulo Sao Paulo SP
Brazil Instituto do Cancer Arnaldo Vieira de Carvalho Sao Paulo SP
Brazil Universidade Federal de Sao Paulo - UNIFESP/EPM Sao Paulo SP
Chile Clinica Las Condes Santiago
Chile Clinica Santa Maria Santiago
Chile Departmento de Hemato-Oncologia Santiago Las Condes
Chile FundacionArturo Lopez Perez Santiago
Chile Hospital Clinico Universidad de Chile Santiago
Chile Hospital FACH Santiago
Chile Hospital Militar Santiago
Chile Instituto Nacional del Cancer Santiago
Chile Instituto Nacional del Cancer - Servicio de Radioterapia Santiago
Germany Stadtisches Krankenhaus Martha-Maria Halle-Dolau GmbH Haale
Germany Allgemeines Kraken Haus St. Georg Onkologie Hamburg
Germany IORC GmbH Hamburg
Germany Thoraxklinik-Heidelberg GmbH Heidelberg Rohrbach BW
Germany Laborgemeinschaft Hamburg Lademannbogen 8 Hamburg
Germany Allgemeines Krankenhaus St. Georg Lohmuehlstr.5 Hamburg
Germany Askllepios Fachkliniken Robert-Koch-Allee 2 Gauting
Germany St. Vincentius-Kliniken gAG Sudendstrasse 32 Karlshure
Germany KH GroBhansdorf - Abt. fuer Thoraxonkologie Woehrendamm 80 Grosshansdorf
Italy Azienda Ospedaliera di Parma - U.O. di Oncologia Parma
Italy Ospedale "Carlo Poma" - Divisione di Oncologia Medica ed Via Albertoni Mantova
Italy Ospedale Garibaldi di Nesima - Oncologia Medica Via Palermo Catania
United Kingdom Bristol Haemotolgy and Oncology Centre Bristol
United Kingdom Div. of cancer Medicine - Princess Alexandra Centre-Ninewells Hospital & Medical School Dundee
United Kingdom Department of Medical Oncology West Smithfield London
United States New York Oncology Hematology, P. C. Albany New York
United States New Mexico Oncology Hematology Consultants, Ltd. Albuquerque New Mexico
United States Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PA Altamonte Springs Florida
United States St. Joseph Mercy Hospital, Cancer Center, OC 139 Ann Arbor Michigan
United States Annapolis Oncology Center Annapolis Maryland
United States East Bay Medical Oncology/Hematology Medical Associates, Inc. Antioch California
United States Arlington Cancer Center Arlington Texas
United States Business Park Drive Armonk New York
United States Peachtree Hematology & Oncology Consultants, P. C. Atlanta Georgia
United States Auerbach Hematology Oncology Associates Baltimore Maryland
United States Franklin Square Hospital Center Baltimore Maryland
United States North Shore Oncology Hematology Associates Barrington Illinois
United States Little Rock Hematology Oncology Benton Benton Arkansas
United States Highlands Oncology Group Bentonville Arkansas
United States Center for Cancer and Blood Disorders Bethesda Maryland
United States Vita Hematology Oncology, P.C. Bethlehem Pennsylvania
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Department of Veterans Affairs Medical Center Birmingham Alabama
United States UAB CCC Clinical Studies Unit Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Cancer Treatment & Research Center Bismarck North Dakota
United States Odyssey Research Bismarck North Dakota
United States The Center for Hematology/Oncology Boca Raton Florida
United States Florida Cancer Specialists Bonita Springs Florida
United States Florida Cancer Specialists Bradenton Florida
United States Albert Einstein Cancer Center at the Montefiore Medical Park Bronx New York
United States Montefiore Medical Center Bronx New York
United States The Jack D. Weiler Hospital of the Albert Einstein College of Medicine Bronx New York
United States East Valley Hematology Oncology Medical Group Burbank California
United States Providence Saint Joseph Medical Center Burbank California
United States Florida Cancer Specialists Cape Coral Florida
United States Raleigh Hematology Oncology Associates Cary North Carolina
United States Raleigh Hematology Oncology Association Cary North Carolina
United States Medical University of S.C. Charleston South Carolina
United States Carolinas HealthCare System/Carolinas Medical Center Charlotte North Carolina
United States Carolinas Hematology-Oncology Associates Charlotte North Carolina
United States Chattanooga Oncology & Hemtology Associates, P. C. Chattanooga Tennessee
United States Memorial Hospital Chattanooga Tennessee
United States Swedish Covenant Cancer Center Chicago Illinois
United States Marilyn Norton, M. D. Chula Vista California
United States Rosalba Rodriquez, M. D. Chula Vista California
United States Hitesh Patel Clearwater Florida
United States Joseph DeFelice Clearwater Florida
United States Morton Plant Hospital Clearwater Florida
United States Oncology Physicians Clearwater Florida
United States Oncology Physicians Clearwater Florida
United States Case Western Reserve University- University Hospitals of Cleveland Cleveland Ohio
United States Space Coast Medical Associates Cocoa Beach Florida
United States Boone Hospital Center Columbia Missouri
United States Ellis Fischel Cancer Center - University of Missouri Health Care Columbia Missouri
United States Missouri Cancer Associates Columbia Missouri
United States Mid Ohio Oncology/Hematology Columbus Ohio
United States Mid Ohio Oncology/Hematology, Inc. Columbus Ohio
United States Mid Ohio Oncology/Hematology, Inc. Columbus Ohio
United States Bay Area Cancer Research Group Concord California
United States Center for Oncology Research and Treatment, PA Dallas Texas
United States Dallas Oncology Consultants, PA Dallas Texas
United States Dallas Oncology Consultants, PA Dallas Texas
United States Texas Cancer Associates, LLP Dallas Texas
United States Genesis Health System Davenport Iowa
United States Cancer Care Specialists of Central IL Decatur Illinois
United States Decatur Memorial Hospital/Clinical Research Decatur Illinois
United States The Center for Hematology/Oncology Delray Beach Florida
United States Duluth Clinic Duluth Minnesota
United States Regional Hematology Oncology Associates Durham North Carolina
United States Regional Hematology Oncology Association Durham North Carolina
United States Cancer Centers of the Carolinas Easley South Carolina
United States Central Jersey Oncology Center East Brunswick New Jersey
United States North Shore Hematology Oncology Associates, P.C. East Setauket New York
United States Cancer Care Specialists of Central IL Effingham Illinois
United States Elkhart General Hospital Elkhart Indiana
United States VLCC-Elkhorn Elkhorn Wisconsin
United States Community Health Partners, Ireland Cancer Center Elyria Ohio
United States Dakota Cancer Institute Fargo North Dakota
United States Odyssey Research Fargo North Dakota
United States Highlands Oncology Group Fayetteville Arkansas
United States Peachtree Hematology & Oncology Consultants, P. C. Fayetteville Georgia
United States Northwest Medical Specialists, PLLC Federal Way Washington
United States Joliet Oncology-Hematology Associates, Ltd. Flossmoor Illinois
United States Broward Oncology Associates Fort Lauderdale Florida
United States Florida Cancer Specialists Fort Myers Florida
United States Florida Cancer Specialists Fort Myers Florida
United States Florida Cancer Speicalists Fort Myers Florida
United States Southwest Fort Worth Cancer Center Fort Worth Texas
United States The Consultant Group, P.C. Franklin Tennessee
United States Queens Medical Associates Fresh Meadows New York
United States Broward Oncology Associates Ft. Lauderdale Florida
United States Texas Oncology, P.A. Ft. Worth Texas
United States Galesburg Cottage Hospital Galesburg Illinois
United States Medical & Surgical Specialists, LLC Galesburg Illinois
United States St. Mary Medical Center Galesburg Illinois
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Gallatin Tennessee
United States Gaston Hematology & Oncology Associates Gastonia North Carolina
United States Palo Verde Hematology Oncology Glendale Arizona
United States Wilshire Oncology Medical Group, Inc. Glendora California
United States Center for Cancer CAre at Goshen Health System Goshen Indiana
United States Cancer Centers of the Carolinas Greenville South Carolina
United States Cancer Centers of the Carolinas Greenville South Carolina
United States Cancer Centers of the Carolinas Greenwood South Carolina
United States Medical Oncology & Hematology, P. C. Hamden Connecticut
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Hermitage Tennessee
United States South Florida Oncology Hematology Hollywood Florida
United States Kapiolani Medical Center for Women & Children Honolulu Hawaii
United States Straub Clinic & Hospital Honolulu Hawaii
United States Heritage Physician Group, Oncology Hot Springs Arkansas
United States The University of Texas - M. D. Anderson Cancer Center Houston Texas
United States Indiana University Cancer Center Indianapolis Indiana
United States Indiana University-Clarian Health Partners Indianapolis Indiana
United States Veterans Administration Indianapolis Indiana
United States Wishard Hospital Indianapolis Indiana
United States Florida Oncology Associates Jacksonville Florida
United States Florida Oncology Associates Jacksonville Florida
United States Florida Oncology Associates Jacksonville Florida
United States Florida Oncology Associates Jacksonville Florida
United States Shands Jacksonville Jacksonville Florida
United States University of Florida/Jacksonville Faculty Clinic Jacksonville Florida
United States Florida Oncology Associates Jacksonville Beach Florida
United States Cancer Care Center Jeffersonville Indiana
United States Joliet Oncology-Hematology Associates, Ltd. Joliet Illinois
United States Freeman Cancer Institute Joplin Missouri
United States Freeman Health System Joplin Missouri
United States Kansas City Cancer Center Kansas City Missouri
United States Kansas City Cancer Center Kansas City Missouri
United States Kansas City Cancer Center Kansas City Missouri
United States Kansas City Cancer Center Kansas City Kansas
United States Associates in Oncology/Hematology, P.C. Kensington Maryland
United States Baptist Hospital of East Tennessee Knoxville Tennessee
United States Baptist Hospital West Knoxville Tennessee
United States East Tennessee Oncology/Hematology, P.C. Knoxville Tennessee
United States East Tennessee Oncology/Hematology, P.C. Knoxville Tennessee
United States Thompson Oncology Group Knoxville Tennessee
United States Thompson Oncology Group Knoxville Tennessee
United States Grossmont Hospital La Mesa California
United States Sharp Rees-Stealy La Mesa California
United States LaPorte Hospital La Porte Indiana
United States Wilshire Oncology Medical Group, Inc. La Verne California
United States Deerpath Medical Associates Lake Forest Illinois
United States Lakeland Regional Cancer Center Lakeland Florida
United States Lakeland Regional Medical Center Lakeland Florida
United States Northwest Medical Specialties, PLLC Lakewood Washington
United States Sparrow Health System Lansing Michigan
United States Sparrow Health System Lansing Michigan
United States Nevada Cancer Centers Las Vegas Nevada
United States Nevada Cancer Centers Las Vegas Nevada
United States New York Oncology Hematology, P.C. Latham New York
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Lebanon Tennessee
United States Kansas City Cancer Center Lee's Summit Missouri
United States North Shore Oncology Hematology Associates Libertyville Illinois
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Alice Hyde Medical Center Malone New York
United States Myrna Sanchez, MD Malone New York
United States Thompson Oncology Group Maryville Tennessee
United States North Shore Oncology Hematology Associates McHenry Illinois
United States Medical Oncology & Hematology, P.C. Meriden Connecticut
United States Space Coast Medical Associates Merritt Island Florida
United States Medical Consultants, Ltd. Milwaukee Wisconsin
United States North Valley Hematology Oncology Group Mission Hills California
United States Providence Holy Cross Medical Center Mission Hills California
United States Beverly Oncology & Imaging Montebello California
United States Beverly Oncology and Imaging Center, Inc. Montebello California
United States Clinical Trials & Research Associates, Inc. Montebello California
United States Clinical Trials and Research Associates, Inc. Montebello California
United States Oncology Care Medical Associates, Inc. Montebello California
United States Joliet Oncology-Hematology Associates, Ltd. Morris Illinois
United States Medical Consultants, PC Muncie Indiana
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Murfreesboro Tennessee
United States Florida Cancer Specialists Naples Florida
United States Florida Cancer Specialists Naples Florida
United States The Consultant Group, P.C. Nashville Tennessee
United States The Sarah Cannon Cancer Center Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States Shore Cancer Center Nassawadox Virginia
United States Cancer Care Center New Albany Indiana
United States Ball Cancer Center at Forest Ridge Medical Pavilion New Castle Indiana
United States Medical Oncology & Hematology, P. C. New Haven Connecticut
United States Medical Oncology & Hematology, P. C. New Haven Connecticut
United States New Milford Hospital New Milford Connecticut
United States Northwestern Connecticut Oncology/Hematology New Milford Connecticut
United States University Hospital Newark New Jersey
United States Lakeland Hospital Niles Michigan
United States Cancer Care Associates Norman Oklahoma
United States Cumberland Oncology & Hematology Oak Ridge Tennessee
United States Mohammad Kamal, M. D. Ocala Florida
United States Ocala Research Institute, Inc. Ocala Florida
United States N. County Oncology Medical Oceanside California
United States Cancer Care Associates Oklahoma City Oklahoma
United States Cancer Care Associates Oklahoma City Oklahoma
United States Cancer Care Associates Oklahoma City Oklahoma
United States Cancer Care Associates Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States Florida Oncology Associates Orange Park Florida
United States UHHS Chagrin Highlands - Ireland Cancer Center Orange Village Ohio
United States Florida Hospital Orlando Florida
United States Hematology & Oncology Consultants, PA Orlando Florida
United States Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PA Orlando Florida
United States Florida Hospital Memorial Division, Cancer Care Center Ormond Beach Florida
United States Kansas City Cancer Center Overland Park Kansas
United States Florida Oncology Associates Palatka Florida
United States Palm Beach Cancer Institute Palm Beach Gardens Florida
United States Wilshire Oncology Medical Group, Inc. Pasadena California
United States Greater Philadelphia Cancer and Hematology Specialists, PC Philadelphia Pennsylvania
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Wilshire Oncology Medical Group, Inc. Pomona California
United States Florida Cancer Specialists Port Charlotte Florida
United States Hematology/Oncology Associates of The Treasure Coast Port St. Lucie Florida
United States Kaiser Permanente Northwest Region Portland Oregon
United States Raleigh Hematology Oncology Associates Raleigh North Carolina
United States Raleigh Hematology Oncology Associates Raleigh North Carolina
United States Raleigh Hematology Oncology Association Raleigh North Carolina
United States Raleigh Hematology Oncology Association Raleigh North Carolina
United States Wilshire Oncology Medical Group, Inc. Rancho Cucamonga California
United States Center for Oncology Research and Treatment, PA Richardson Texas
United States Associates in Oncology/Hematology, P.C. Rockville Maryland
United States Medical Oncology Associates - SD San Diego California
United States Sharp Memorial Hospital San Diego California
United States Sharp Rees-Stealy San Diego California
United States Southern California Permanente Medical Group San Diego California
United States Oncology Care Medical Associates, Inc. San Gabriel California
United States East Bay Medical Oncology/Hematology Medcial Associates, Inc. San leandro California
United States Santa Monica Hematology/Oncology Santa Monica California
United States Florida Cancer Specialists Sarasota Florida
United States Florida Cancer Specialists Sarasota Florida
United States Guthrie Clinic Sayre Pennsylvania
United States Robert Packer Hospital Sayre Pennsylvania
United States Horizons West Medical Group Scottsbluff Nebraska
United States Cancer Centers of the Carolinas Seneca South Carolina
United States Northwestern Connecticut Oncology/Hematology Sharon Connecticut
United States Sharon Hospital Sharon Connecticut
United States Hematology Oncology Associates of Illinois (HOAI) Skokie Illinois
United States Midwest Cancer Research Group, Inc. Skokie Illinois
United States North Shore Cancer Research Association Skokie Illinois
United States Aurora Health Center-Slinger Slinger Wisconsin
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Smyrna Tennessee
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph's Regional Medical Center South Bend Indiana
United States Cancer Centers of the Carolinas Spartanburg South Carolina
United States Highlands Oncology Group Springdale Arkansas
United States Florida Oncology Associates St. Augustine Florida
United States Lakeland Hospital St. Joseph Michigan
United States Missouri Baptist Medical Center St. Louis Missouri
United States Northwest Medical Specialists, PLLC Tacoma Washington
United States Charlotte Hungerford Hospital Torrington Connecticut
United States Northwestern Connecticut Oncology/Hematology Torrington Connecticut
United States Cancer Care Associates Tulsa Oklahoma
United States Cancer Care Associates Tulsa Oklahoma
United States Cancer Care Associates Tulsa Oklahoma
United States Florida Cancer Specialists Venice Florida
United States Florida Cancer Specialists Venice Florida
United States Medical Center of Vincennes Vincennes Indiana
United States Tricare Vincennes Indiana
United States Cooper Cancer Institute Voorhees New Jersey
United States Diablo Valley Oncology & Hematology Medical Group, Inc. Walnut Creek California
United States Georgetown University Hospital Washington District of Columbia
United States Washington Hospital Center - Washington Cancer Institute Washington District of Columbia
United States Medical Oncology & Hematology, P.C. Waterbury Connecticut
United States Palm Beach Cancer Institute Wellington Florida
United States VLCC-West Bend West Bend Wisconsin
United States Wilshire Oncology Medical Group, Inc. West Covina California
United States Palm Beach Cancer Institute West Palm Beach Florida
United States Mid Ohio Oncology/Hematology, Inc. Westerville Ohio
United States UHHS Westlake - Ireland Cancer Center Westlake Ohio
United States Oncology Care Medical Associates, Inc. Whittier California
United States Piedmont Hematology Oncology Associates Winston Salem North Carolina
United States Hematology & Oncology Consultants, PA Winter Park Florida
United States Department of Hematology/Oncology Worcester Massachusetts
United States Fallon Clinic Pharmacy-Linda Tolf, R.Ph. Worcester Massachusetts
United States Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.D Worcester Massachusetts
United States Midwestern Regional Medical Center Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Telik

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  Germany,  Italy,  United Kingdom, 

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