Non Small Cell Lung CarcinomaPhase 3NCT00080340
Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing TLK286 (Telcyta) HCl for Injection and gefitinib (Iressa) in people with Non Small Cell Lung Carcinoma, run by Telik at 338 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- TLK286 (Telcyta) HCl for Injection and gefitinib (Iressa)
- Type of treatment
- Injection or infusion
- How many people
- 520 participants
- Where
- 338 sitesin 8 countries
- Study dates
- Start not givento May 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
338 sites in 8 countries.
338 sites in 8 countries
United States270 sites
New York Oncology Hematology, P. C.
Albany, New York, 12208
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109
Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PA
Altamonte Springs, Florida, 32701
St. Joseph Mercy Hospital, Cancer Center, OC 139
Ann Arbor, Michigan, 48106
Annapolis Oncology Center
Annapolis, Maryland, 21401
East Bay Medical Oncology/Hematology Medical Associates, Inc.
Antioch, California, 94509
Arlington Cancer Center
Arlington, Texas, 76012
Business Park Drive
Armonk, New York, 10504
Peachtree Hematology & Oncology Consultants, P. C.
Atlanta, Georgia, 30309
Auerbach Hematology Oncology Associates
Baltimore, Maryland, 21237
Franklin Square Hospital Center
Baltimore, Maryland, 21237
North Shore Oncology Hematology Associates
Barrington, Illinois, 60010
Little Rock Hematology Oncology Benton
Benton, Arkansas, 72015
Highlands Oncology Group
Bentonville, Arkansas, 72702
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Vita Hematology Oncology, P.C.
Bethlehem, Pennsylvania, 18015
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
UAB CCC Clinical Studies Unit
Birmingham, Alabama, 35233-2115
Department of Veterans Affairs Medical Center
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cancer Treatment & Research Center
Bismarck, North Dakota, 58501
Odyssey Research
Bismarck, North Dakota, 58501
The Center for Hematology/Oncology
Boca Raton, Florida, 33486
Florida Cancer Specialists
Bonita Springs, Florida, 34135
Florida Cancer Specialists
Bradenton, Florida, 34209
East Valley Hematology Oncology Medical Group
Burbank, California, 91505
Providence Saint Joseph Medical Center
Burbank, California, 91505
Florida Cancer Specialists
Cape Coral, Florida, 33990
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27511
Raleigh Hematology Oncology Association
Cary, North Carolina, 27511
Medical University of S.C.
Charleston, South Carolina, 29425
Carolinas HealthCare System/Carolinas Medical Center
Charlotte, North Carolina, 28203
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, 28203
Chattanooga Oncology & Hemtology Associates, P. C.
Chattanooga, Tennessee, 37404
Memorial Hospital
Chattanooga, Tennessee, 37404
Swedish Covenant Cancer Center
Chicago, Illinois, 60625
Marilyn Norton, M. D.
Chula Vista, California, 91911
Rosalba Rodriquez, M. D.
Chula Vista, California, 91911
Hitesh Patel
Clearwater, Florida, 33756
Joseph DeFelice
Clearwater, Florida, 33756
Morton Plant Hospital
Clearwater, Florida, 33756
Oncology Physicians
Clearwater, Florida, 33756
Oncology Physicians
Clearwater, Florida, 33761
Case Western Reserve University- University Hospitals of Cleveland
Cleveland, Ohio, 44106
Space Coast Medical Associates
Cocoa Beach, Florida, 32931
Boone Hospital Center
Columbia, Missouri, 65201
Missouri Cancer Associates
Columbia, Missouri, 65201
Ellis Fischel Cancer Center - University of Missouri Health Care
Columbia, Missouri, 65203
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43215
Mid Ohio Oncology/Hematology
Columbus, Ohio, 43222
Bay Area Cancer Research Group
Concord, California, 94520
Dallas Oncology Consultants, PA
Dallas, Texas, 75208
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230
Texas Cancer Associates, LLP
Dallas, Texas, 75231
Dallas Oncology Consultants, PA
Dallas, Texas, 75237
Genesis Health System
Davenport, Iowa, 52803
Cancer Care Specialists of Central IL
Decatur, Illinois, 62526
Decatur Memorial Hospital/Clinical Research
Decatur, Illinois, 62526
The Center for Hematology/Oncology
Delray Beach, Florida, 33484
Duluth Clinic
Duluth, Minnesota, 55805
Regional Hematology Oncology Associates
Durham, North Carolina, 27704
Regional Hematology Oncology Association
Durham, North Carolina, 27704
Cancer Centers of the Carolinas
Easley, South Carolina, 29640
Central Jersey Oncology Center
East Brunswick, New Jersey, 08816
North Shore Hematology Oncology Associates, P.C.
East Setauket, New York, 11733
Cancer Care Specialists of Central IL
Effingham, Illinois, 62401
Elkhart General Hospital
Elkhart, Indiana, 46514
VLCC-Elkhorn
Elkhorn, Wisconsin, 53121
Community Health Partners, Ireland Cancer Center
Elyria, Ohio, 44035
Dakota Cancer Institute
Fargo, North Dakota, 58103
Odyssey Research
Fargo, North Dakota, 58103
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Peachtree Hematology & Oncology Consultants, P. C.
Fayetteville, Georgia, 30214
Northwest Medical Specialists, PLLC
Federal Way, Washington, 98003
Joliet Oncology-Hematology Associates, Ltd.
Flossmoor, Illinois, 60422
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
Florida Cancer Specialists
Fort Myers, Florida, 33901
Florida Cancer Speicalists
Fort Myers, Florida, 33901
Florida Cancer Specialists
Fort Myers, Florida, 33908
Texas Oncology, P.A.
Fort Worth, Texas, 76104
Southwest Fort Worth Cancer Center
Fort Worth, Texas, 76132
The Consultant Group, P.C.
Franklin, Tennessee, 37067
Queens Medical Associates
Fresh Meadows, New York, 11365
Galesburg Cottage Hospital
Galesburg, Illinois, 61401
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
St. Mary Medical Center
Galesburg, Illinois, 61401
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066
Gaston Hematology & Oncology Associates
Gastonia, North Carolina, 28054
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
Wilshire Oncology Medical Group, Inc.
Glendora, California, 91741
Center for Cancer CAre at Goshen Health System
Goshen, Indiana, 46526
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Cancer Centers of the Carolinas
Greenwood, South Carolina, 29646
Medical Oncology & Hematology, P. C.
Hamden, Connecticut, 06518
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076
South Florida Oncology Hematology
Hollywood, Florida, 33021
Straub Clinic & Hospital
Honolulu, Hawaii, 96813
Kapiolani Medical Center for Women & Children
Honolulu, Hawaii, 96826
Heritage Physician Group, Oncology
Hot Springs, Arkansas, 71913
The University of Texas - M. D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Indiana University-Clarian Health Partners
Indianapolis, Indiana, 46202
Veterans Administration
Indianapolis, Indiana, 46202
Wishard Hospital
Indianapolis, Indiana, 46202
Florida Oncology Associates
Jacksonville, Florida, 32204
Florida Oncology Associates
Jacksonville, Florida, 32207
Shands Jacksonville
Jacksonville, Florida, 32209
University of Florida/Jacksonville Faculty Clinic
Jacksonville, Florida, 32209
Florida Oncology Associates
Jacksonville, Florida, 32218
Florida Oncology Associates
Jacksonville, Florida, 32223
Florida Oncology Associates
Jacksonville Beach, Florida, 32250
Cancer Care Center
Jeffersonville, Indiana, 47130
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Freeman Cancer Institute
Joplin, Missouri, 64804
Freeman Health System
Joplin, Missouri, 64804
Kansas City Cancer Center
Kansas City, Kansas, 66112
Kansas City Cancer Center
Kansas City, Missouri, 64111
Kansas City Cancer Center
Kansas City, Missouri, 64131
Kansas City Cancer Center
Kansas City, Missouri, 64154
Associates in Oncology/Hematology, P.C.
Kensington, Maryland, 20895
Thompson Oncology Group
Knoxville, Tennessee, 37916
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920
East Tennessee Oncology/Hematology, P.C.
Knoxville, Tennessee, 37920
Baptist Hospital West
Knoxville, Tennessee, 37922
East Tennessee Oncology/Hematology, P.C.
Knoxville, Tennessee, 37922
Thompson Oncology Group
Knoxville, Tennessee, 37932
Grossmont Hospital
La Mesa, California, 91942
Sharp Rees-Stealy
La Mesa, California, 91942
LaPorte Hospital
La Porte, Indiana, 46350
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750
Deerpath Medical Associates
Lake Forest, Illinois, 60045
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Lakeland Regional Medical Center
Lakeland, Florida, 33805
Northwest Medical Specialties, PLLC
Lakewood, Washington, 98499
Sparrow Health System
Lansing, Michigan, 48909
Sparrow Health System
Lansing, Michigan, 48912
Nevada Cancer Centers
Las Vegas, Nevada, 89109
Nevada Cancer Centers
Las Vegas, Nevada, 89128
New York Oncology Hematology, P.C.
Latham, New York, 12110
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087
Kansas City Cancer Center
Lee's Summit, Missouri, 64064
North Shore Oncology Hematology Associates
Libertyville, Illinois, 60048
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Alice Hyde Medical Center
Malone, New York, 12953
Myrna Sanchez, MD
Malone, New York, 12953
Thompson Oncology Group
Maryville, Tennessee, 37804
North Shore Oncology Hematology Associates
McHenry, Illinois, 60050
Medical Oncology & Hematology, P.C.
Meriden, Connecticut, 06451
Space Coast Medical Associates
Merritt Island, Florida, 32952
Medical Consultants, Ltd.
Milwaukee, Wisconsin, 53215
North Valley Hematology Oncology Group
Mission Hills, California, 91345
Providence Holy Cross Medical Center
Mission Hills, California, 91345
Clinical Trials and Research Associates, Inc.
Montebello, California, 60460
Beverly Oncology & Imaging
Montebello, California, 90640
Beverly Oncology and Imaging Center, Inc.
Montebello, California, 90640
Clinical Trials & Research Associates, Inc.
Montebello, California, 90640
Oncology Care Medical Associates, Inc.
Montebello, California, 90640
Joliet Oncology-Hematology Associates, Ltd.
Morris, Illinois, 60450
Medical Consultants, PC
Muncie, Indiana, 47303
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130
Florida Cancer Specialists
Naples, Florida, 34102
Florida Cancer Specialists
Naples, Florida, 34119
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
The Consultant Group, P.C.
Nashville, Tennessee, 37205
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Nashville, Tennessee, 37205
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Nashville, Tennessee, 37207
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Nashville, Tennessee, 37211
Shore Cancer Center
Nassawadox, Virginia, 23413
Cancer Care Center
New Albany, Indiana, 47150
Ball Cancer Center at Forest Ridge Medical Pavilion
New Castle, Indiana, 47362
Medical Oncology & Hematology, P. C.
New Haven, Connecticut, 06510
Medical Oncology & Hematology, P. C.
New Haven, Connecticut, 06511
New Milford Hospital
New Milford, Connecticut, 06776
Northwestern Connecticut Oncology/Hematology
New Milford, Connecticut, 06776
University Hospital
Newark, New Jersey, 07103
Lakeland Hospital
Niles, Michigan, 49120
Cancer Care Associates
Norman, Oklahoma, 73071
Cumberland Oncology & Hematology
Oak Ridge, Tennessee, 37830
Mohammad Kamal, M. D.
Ocala, Florida, 34471
Ocala Research Institute, Inc.
Ocala, Florida, 34480
N. County Oncology Medical
Oceanside, California, 92056
Cancer Care Associates
Oklahoma City, Oklahoma, 73102
Cancer Care Associates
Oklahoma City, Oklahoma, 73109
Cancer Care Associates
Oklahoma City, Oklahoma, 73112
Cancer Care Associates
Oklahoma City, Oklahoma, 73120
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
UHHS Chagrin Highlands - Ireland Cancer Center
Orange, Ohio, 44122
Florida Oncology Associates
Orange Park, Florida, 32073
Florida Hospital
Orlando, Florida, 32603
Hematology & Oncology Consultants, PA
Orlando, Florida, 32804
Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PA
Orlando, Florida, 32804
Florida Hospital Memorial Division, Cancer Care Center
Ormond Beach, Florida, 32174
Kansas City Cancer Center
Overland Park, Kansas, 66210
Florida Oncology Associates
Palatka, Florida, 32177
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, 33410
Wilshire Oncology Medical Group, Inc.
Pasadena, California, 91105
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Greater Philadelphia Cancer and Hematology Specialists, PC
Philadelphia, Pennsylvania, 19114
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767
Florida Cancer Specialists
Port Charlotte, Florida, 33980
Hematology/Oncology Associates of The Treasure Coast
Port Saint Lucie, Florida, 34952
Kaiser Permanente Northwest Region
Portland, Oregon, 97227
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607
Raleigh Hematology Oncology Association
Raleigh, North Carolina, 27607
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27609
Raleigh Hematology Oncology Association
Raleigh, North Carolina, 27609
Wilshire Oncology Medical Group, Inc.
Rancho Cucamonga, California, 91730
Center for Oncology Research and Treatment, PA
Richardson, Texas, 75080
Associates in Oncology/Hematology, P.C.
Rockville, Maryland, 20850
Florida Oncology Associates
Saint Augustine, Florida, 32086
Lakeland Hospital
Saint Joseph, Michigan, 49085-2158
Southern California Permanente Medical Group
San Diego, California, 92120
Medical Oncology Associates - SD
San Diego, California, 92123
Sharp Memorial Hospital
San Diego, California, 92123
Sharp Rees-Stealy
San Diego, California, 92123
Oncology Care Medical Associates, Inc.
San Gabriel, California, 91776
East Bay Medical Oncology/Hematology Medcial Associates, Inc.
San Leandro, California, 94578
Santa Monica Hematology/Oncology
Santa Monica, California, 90404
Florida Cancer Specialists
Sarasota, Florida, 34232
Florida Cancer Specialists
Sarasota, Florida, 34236
Guthrie Clinic
Sayre, Pennsylvania, 18840
Robert Packer Hospital
Sayre, Pennsylvania, 18840
Horizons West Medical Group
Scottsbluff, Nebraska, 69361
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672
Northwestern Connecticut Oncology/Hematology
Sharon, Connecticut, 06069
Sharon Hospital
Sharon, Connecticut, 06069
Hematology Oncology Associates of Illinois (HOAI)
Skokie, Illinois, 60076
Midwest Cancer Research Group, Inc.
Skokie, Illinois, 60076
North Shore Cancer Research Association
Skokie, Illinois, 60076
Aurora Health Center-Slinger
Slinger, Wisconsin, 53086
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Saint Joseph's Regional Medical Center
South Bend, Indiana, 46617
Cancer Centers of the Carolinas
Spartanburg, South Carolina, 29307
Highlands Oncology Group
Springdale, Arkansas, 72764
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Northwest Medical Specialists, PLLC
Tacoma, Washington, 98405
Albert Einstein Cancer Center at the Montefiore Medical Park
The Bronx, New York, 10461
The Jack D. Weiler Hospital of the Albert Einstein College of Medicine
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
Charlotte Hungerford Hospital
Torrington, Connecticut, 06790
Northwestern Connecticut Oncology/Hematology
Torrington, Connecticut, 06790
Cancer Care Associates
Tulsa, Oklahoma, 74104
Cancer Care Associates
Tulsa, Oklahoma, 74133
Cancer Care Associates
Tulsa, Oklahoma, 74136
Florida Cancer Specialists
Venice, Florida, 34285
Florida Cancer Specialists
Venice, Florida, 34292
Medical Center of Vincennes
Vincennes, Indiana, 47591
Tricare
Vincennes, Indiana, 47591
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043
Diablo Valley Oncology & Hematology Medical Group, Inc.
Walnut Creek, California, 94598
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Washington Hospital Center - Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Medical Oncology & Hematology, P.C.
Waterbury, Connecticut, 06708
Palm Beach Cancer Institute
Wellington, Florida, 33414
VLCC-West Bend
West Bend, Wisconsin, 53095
Wilshire Oncology Medical Group, Inc.
West Covina, California, 91790
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
Mid Ohio Oncology/Hematology, Inc.
Westerville, Ohio, 43081
UHHS Westlake - Ireland Cancer Center
Westlake, Ohio, 44145
Oncology Care Medical Associates, Inc.
Whittier, California, 90602
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103
Hematology & Oncology Consultants, PA
Winter Park, Florida, 32792
Department of Hematology/Oncology
Worcester, Massachusetts, 01608
Fallon Clinic Pharmacy-Linda Tolf, R.Ph.
Worcester, Massachusetts, 01608
Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.D
Worcester, Massachusetts, 01608
Midwestern Regional Medical Center
Zion, Illinois, 60099
Brazil17 sites
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, 30180-090
Hospital das Clinicas da UFPR
Curitiba, Paraná, 80060-150
Pro Onco Centro de Tratamento Oncologico S/C Ltda.
Curitiba, Paraná, 86010-640
Instituto do Cancer do Ceara
Fortaleza, Ceará, 60430-230
Associacao de Combate ao cancer de Goias - Hospital
Goiânia, Goiás, 74605-070
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Sao Lucas-PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-070
Santo Andre Diagnostico e Tratamento Ltda
Santo André, São Paulo, 09090-780
Santo Andre Diagnosticos e Tratamentos Ltda.
Santo André, São Paulo, 09090-780
Santo Andre Diagnosticos e Tratamentos
Santo André, São Paulo, 09090-780
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, São Paulo, 01224-010
Complexo Hospitalar Heliopolis
São Paulo, São Paulo, 01327-002
Universidade Federal de Sao Paulo - UNIFESP/EPM
São Paulo, São Paulo, 04039-032
Hospital das Clinicas - Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Fundacao Pio XII - Hospital do Cancer de Barretos
São Paulo, São Paulo, 14784-400
Conjunto Hospitalar de Sorocaba
São Paulo, São Paulo, 18030-210
Australia14 sites
Albury Base Hospital
Albury, New South Wales, 2640
West Albury Barker's Pharmacy
Albury, New South Wales, 2640
Bankstown Lidcombe Hospital - Department of Medical Oncology
Bankstown, 2200
Flinders Medical Centre
Bedford Park, South Australia, 5041
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Royal Hobart Hospital
Hobart, 7000
Sir Charles Gairdner Hospital
Nedlands, 6009
Department Of Oncology
South Brisbane, Queensland, 4101
Royal North Shore Hospital-Medical Oncology Dept.
St Leonards, 2065
Department of Medical Oncology-Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Pharmatel Fresenius Kabi Pty Ltd.
West Melbourne, Victoria, 3003
Murray Valley Private Hospital
Wodonga, Victoria, 3690
Border Medical Oncology - Murray Valley Private Hospital
Wodonga, 3690
Clinical Trials Centre - Wollongong Hospital
Wollongong, 2500
Argentina13 sites
Policlinica Privada Instituto de Medicina Nuclear
Bahía Blanca, Buenos Aires, B8000LMA
Instituto Alexander flaming
Buenos Aires, Buenos Aires, C1426ANZ
Complejo Medico de la Policia Federal Argentina "Churruca-Visca" - Servicio de Oncologia
Buenos Aires, 1437
Hospital General de Agudos "Carlos G. Durand" - Servicio de Oncologia
Buenos Aires, C1405DCS
Hospital Britanico de Buenos Aires
Capital Federal, Buenos Aires, C1280AEB
Hospital de Oncologia Maria Curie
Capital Federal, Buenos Aires, C1405BWU
Hospital Alvarez
Capital Federal, Buenos Aires, C1406FWY
Hospital Donacion F. Santojanni
Capital Federal, Buenos Aires, C1408INH
Hospital Privado de Comunidad
Córdoba, Mar Del Plata, 7602
Sociedad de Beneficencia Hospital Italiano
Córdoba, 5000
Hospital Universitario Austral - Servicio de Oncologia
Pilar, Buenos Aires, 1629
Instituto CAICI
Rosario, 2000
H.I.G.A. Eva Peron
San Martin, 1650
Chile9 sites
Departmento de Hemato-Oncologia
Santiago, Las Condes
Clinica Las Condes
Santiago
Clinica Santa Maria
Santiago
FundacionArturo Lopez Perez
Santiago
Hospital Clinico Universidad de Chile
Santiago
Hospital FACH
Santiago
Hospital Militar
Santiago
Instituto Nacional del Cancer - Servicio de Radioterapia
Santiago
Instituto Nacional del Cancer
Santiago
Germany9 sites
Stadtisches Krankenhaus Martha-Maria Halle-Dolau GmbH
Haale, 06120
Allgemeines Kraken Haus St. Georg Onkologie
Hamburg, 20099
IORC GmbH
Hamburg, 22081
Thoraxklinik-Heidelberg GmbH
Heidelberg, Rohrbach BW, 69126
Laborgemeinschaft Hamburg
Lademannbogen 8, Free and Hanseatic City of Hamburg, 22339
Allgemeines Krankenhaus St. Georg
Lohmuehlstr.5, Free and Hanseatic City of Hamburg, 20099
Askllepios Fachkliniken
Robert-Koch-Allee 2, Gauting, 82131
St. Vincentius-Kliniken gAG
Sudendstrasse 32, Karlshure, 76147
KH GroBhansdorf - Abt. fuer Thoraxonkologie
Woehrendamm 80, Grosshansdorf, 22927
Italy3 sites
Azienda Ospedaliera di Parma - U.O. di Oncologia
Parma, 43100
Ospedale "Carlo Poma" - Divisione di Oncologia Medica ed
Via Albertoni, Mantova, 46100
Ospedale Garibaldi di Nesima - Oncologia Medica
Via Palermo, Catania, 95122
United Kingdom3 sites
Bristol Haemotolgy and Oncology Centre
Bristol, BA21 4AT
Div. of cancer Medicine - Princess Alexandra Centre-Ninewells Hospital & Medical School
Dundee, DD1-9SY
Department of Medical Oncology
West Smithfield, London, EC1A 7BE
About this study
Official title: Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- TLK286 (Telcyta) HCl for Injection, gefitinib (Iressa)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLK286 (Telcyta) HCl for InjectionDrug
gefitinib (Iressa)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2004 (estimated)
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080340
- Sponsor's protocol ID
- TLK286.3020
- Status last verified
- Mar 2006
- First submitted
- 26 Mar 2004
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00080340
- Acronym / sponsor ID
- TLK286.3020
- Conditions
- Non Small Cell Lung Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study completion
- May 2005
- First posted
- 30 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLK286 (Telcyta) HCl for Injection | Drug | – |
| gefitinib (Iressa) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
338 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TLK286 (Telcyta) HCl for Injection and gefitinib (Iressa) in people with Non Small Cell Lung Carcinoma, run by Telik at 338 sites in 8 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 4 inclusion and 5 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 338 sites in United States, Brazil, Australia, Argentina, Chile and 3 more countries. 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.
Where can I read the original study information?
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 15 Jan 2008.