Lung Cancer Clinical Trial

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

Summary

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed stage IIIB or IV NSCLC
Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
At least one target lesion that is unirradiated and measurable by RECIST
Adequate hematologic, renal and hepatic function
ECOG 0, 1, or 2
Able to understand and sign an Informed Consent

Exclusion Criteria:

Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
Serious active infection
Psychiatric illness/ social situations that would limit study compliance
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
Known HIV positive or on active anti-retroviral therapy
Known Hepatitis B surface antigen positive or hepatitis C positive
Receipt of any investigational medication within 4 weeks prior to randomization
Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

742

Study ID:

NCT00707304

Recruitment Status:

Completed

Sponsor:

Agennix

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There are 180 Locations for this study

See Locations Near You

Desert Oasis Cancer Center
Casa Grande Arizona, 85122, United States
Arizona Oncology Associates
Tucson Arizona, 85710, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Pasco Pinellas Cancer Center
New Port Richey Florida, 34652, United States
Emory University
Atlanta Georgia, 30322, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Cancer Care Specialists of Central Illinois
Decatur Illinois, 62526, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles Illinois, 60714, United States
Central Indiana Cancer Centers
Greenfield Indiana, 46140, United States
Kansas City Cancer Center, LLC
Overland Park Kansas, 66210, United States
NCI, CCR, The Waren Grant Magnuson Clinical Center
Bethesda Maryland, 20892, United States
Newland Medical Associates
Southfield Michigan, 48075, United States
Minnesota Oncology and Hematology, PA
Minneapolis Minnesota, 55405, United States
Washington University School of Medicine
St. Louis Missouri, 63128, United States
Southeast Nebraska Cancer Center
Lincoln Nebraska, 68510, United States
NH Oncology-Hematology, PA
Hooksett New Hampshire, 03106, United States
Montefiore Medical Center
Bronx New York, 10467, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Alamance Regional Medical Center
Burlington North Carolina, 27216, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Rex Cancer Center
Raleigh North Carolina, 27609, United States
Legacy Pharma Research
Bismarck North Dakota, 58501, United States
Signal Point Clinical Research Center
Middletown Ohio, 45042, United States
Kaiser Group Health
Portland Oregon, 97227, United States
Texas Oncology
Dallas Texas, 75230, United States
Texas Oncology
Fort Worth Texas, 76104, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem Virginia, 24153, United States
Cancer Care Northwest
Spokane Washington, 99202, United States
Campbelltown Hospital
Campbelltown New South Wales, 2560, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
Townsville Hospital
Townsville Queensland, 4814, Australia
The Queen Elisabeth Hospital
Woodville South South Australia, 5011, Australia
Epworth Healthcare
Richmond Victoria, 3121, Australia
DDODIU-Plovdiv, EOOD
Aleksandur Stamboliyski Plovdiv, 4004, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven , 5800, Bulgaria
DDODIU-Plovdiv, EOOD
Plovdiv , 4004, Bulgaria
DDODIU - Sofia District EOOD
Sofia , 1233, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia , 1527, Bulgaria
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Mount Sinai Hospital
Toronto Ontario, M5G 1, Canada
Hôtel-Dieu de Lévis
Lévis Quebec, G6V 3, Canada
Gerald Bronfman Centre for Clinical Research in Oncology
Montreal Quebec, H3A 1, Canada
Fakultni nemocnice Na Bulovce
Budinova Praha, 180 0, Czech Republic
Institut Onkologie a Rehabilitace Na Plesi
Nova Ves pod Plesi , 262 0, Czech Republic
Vitkovicka nemocnice a.s.
Ostrava , 700 3, Czech Republic
Fakultni Nemocnice Ostrava
Ostrava , 708 5, Czech Republic
Pardubicka krajska nemocnice, a.s.
Pardubice , 532 0, Czech Republic
Fakultni Nemocnice Kralovske Vinohrady
Praha , 100 0, Czech Republic
Fakultni nemocnice v Motole, s.p.
Praha , 150 0, Czech Republic
Oblastni nemocnice Pribram, a.s.
Pribram , 261 9, Czech Republic
Nemocnice Tabor, a.s.
Tabor , 390 0, Czech Republic
Hopital Cardiologique, Chru Lille
Lille Cedex, 590, France
CHU Pontchaillou
Rennes Cedex, 35033, France
CRLCC René Gauducheau
Saint-herblain Cedex, 44805, France
CLCC Paul Strauss
Strasbourg Cedex, 67085, France
Hopital Larrey
Toulouse Cedex, 31059, France
Centre Catherine de Sienne
Eric Tabarly Nantes, 44202, France
CHU Angers
Angers cedex , 49933, France
Hopital Morvan
Brest , 29200, France
Centre Francois Baclesse
Caen Cedex , 14076, France
Centre d'Oncology de Gentilly
Cedex , 54100, France
Centre Hospitalier du Mans
Le Mans Cedex , 72037, France
Centre Léon Berard
Lyon , 69008, France
Hopital Sainte Marguerite
Marseille Cedex 9 , 13274, France
Hôpital Saint-Antoine
Paris , 75012, France
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex , 69495, France
Hopital Maison Blanche
Reims , 51100, France
CHU de Nancy, Hopital de Brabois
Vandoeuvre les Nancy , 54500, France
Praxis fuer interdisziplinaere Onkologie
Freiburg BW, 79106, Germany
Universitaetsklinikum Mannheim
Mannheim BW, 68167, Germany
Universitaetsklinikum Erlangen - PS
Erlangen BY, 91054, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting BY, 82131, Germany
Klinikum rechts der Isar der TU Muenchen
Muenchen BY, 81675, Germany
Gemeinschaftspraxis fuer Haematologie Onkologie
Wiesbaden HE, 65191, Germany
Universitaetsklinikum Goettingen
Goettingen NI, 37075, Germany
St. Johannes Hospital - PS
Dortmund NW, 44137, Germany
Krankenhaus Grosshansdorf
Woehrendamm SH, 22927, Germany
Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle ST, 06120, Germany
Zentralklinik Bad Berka
Bad Berka TH, 99437, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg , 69126, Germany
General Hospital of Chania 'Ag. Georgios'
Mournies Crete, 73300, Greece
University Hospital of Larissa
Mezourlo Larissa, 411 1, Greece
University General Hospital of Patras
Rion Patras, 26505, Greece
General Hospital of Athens "Sotiria"
Athens , 11527, Greece
University Hospital of Heraklio
Crete , 71110, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki , , Greece
Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
Csabai kapu Miskolc, 3529, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Seregelyesi Szekesfehervar, 8000, Hungary
Semmelweis Egyetem
Budapest , 1125, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 1529, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc , 3526, Hungary
Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
Nyiregyháza , 4412, Hungary
Torokbalinti Tudogyogyintezet
Torokbalint , 2045, Hungary
Zala Megyei Korhaz
Zalaegerszeg , 8900, Hungary
King George Hospital
Vishakhapattanam Andhhra Pradesh, 53000, India
Apollo Hospital
Hyderabad Andhra Pradesh, 50003, India
Indo-American Cancer Institute and Research Center
Hyderabad Andhra Pradesh, 50003, India
Kidwai Institute of Oncology
Bangalore Karnataka, 56002, India
M. S. Ramaiah Memorial Hospital
Bangalore Karnataka, 56005, India
A.J. Medical College Hosptial
Mangalore Karnataka, 57500, India
Tata Memorial Hospital
Mumbai Maharashtra, 400 0, India
P.D. Hinduja Nat. Hospital & Med. Research Centre
Mumbai Maharashtra, 40001, India
Kaushalya Medical Foundation Trust Hospital
Mumbai Maharashtra, 40060, India
Cancer Care Clinic
Nagpur Maharashtra, 44001, India
Shatabdi Hospital
Nashik Maharashtra, 42200, India
Deenanath Mangeshkar Hospital and Research Center
Pune Maharashtra, 411 0, India
Searoc Cancer Hospital
Jaipur Rajasthan, 30201, India
Mahaveer Cancer Hospital and Research Centre
Jaipur Rajasthan, 30201, India
Dr. Kamakshi Memorial Hospital Pvt Ltd
Chennai Tamilnadu, 60010, India
Christian Medical College Hospital
Vellore Tamilnadu, 63200, India
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona AN, 60020, Italy
Istituto per la Ricerca e la Cura del Cancro
Candiolo Candiolo/TO, 10060, Italy
Ospedale Versilia
Lido di Camaiore LU, 55043, Italy
Istituto Nazionale Tumori
Milano MI, 20133, Italy
Azienda Ospedaliera San Gerardo
Monza MI, 20052, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, RM, , Italy
Ospedale Mater Salutis
Legnago VR, 37045, Italy
CRO Centro di Riferimento Oncologico di Aviano
Aviano , 33081, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona , 26100, Italy
Chonnam National University Hwasun Hospital
Hwasun up Chonnam, 519-8, Korea, Republic of
National Cancer Center
Ilsandong-gu Goyang, 411-7, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do,, 463-7, Korea, Republic of
Samsung Medical Center
Gangnam-Gu Seoul, 135-7, Korea, Republic of
Seoul National University Hospital
Jongno-gu Seoul, 110-7, Korea, Republic of
Korea University Anam Hospital
Seongbuk-gu Seoul, 136-7, Korea, Republic of
Asan Medical Center
Songpa-gu Seoul, 138-7, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
Paldal-gu Suwon Gyeonggi-do, 442-7, Korea, Republic of
Dr. Anna Levcenko GP and Internist Practice
Daugavpils , LV-54, Latvia
Piejuras Hospital
Liepaja , LV-43, Latvia
Riga Eastern Clinical University Hospital
Riga , LV-10, Latvia
P. Stradina Clinical University Hospital
Riga , LV100, Latvia
Nilai Cancer Institute (NCI Cancer Hospital)
Negeri Sembilan Darul Khusus, 71800, Malaysia
Lam Wah Ee Hospital
Pulau Pinang Georgetown,, 11600, Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian Kelantan, 16150, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan Pahang, 25100, Malaysia
Manila Doctors Hospital
Manila , 1000, Philippines
Lung Center of the Philippines
Quezon City , 1100, Philippines
St. Luke's Medical Center
Quezon City , 1102, Philippines
Akademickie Centrum Kliniczne - Szpital AM w Gdansku
Gdansk , 80-95, Poland
Nzoz Vesalius
Krakow , 31-10, Poland
Miedziowe Centrum Zdrowia S.A.
Lubin , 59-30, Poland
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
Olsztyn , 10-51, Poland
Specjalistyczny Szpital im. Prof. A. Sokolowskiego
Szczecin , 70-89, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa , 02-78, Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Str. Republicii nr. 34-36 Cluj-Napoca, 40001, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
Baia Mare , 43003, Romania
Spitalul Judetean de Urgenta Braila
Braila , 81032, Romania
S.C. Ianuli Med Consult S.R.L.
Bucuresti , 02096, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca , 40001, Romania
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
Suceava , 72023, Romania
Oncology Dispensary #2 of Krasnodar Region
Dagomysskaya str. Sochi, 35405, Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk , 16304, Russian Federation
SHI Altay Regional Oncology Dispensary
Barnaul , 65605, Russian Federation
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
Moscow , 12912, Russian Federation
City Clinical Hospital #1
Novosibirsk , 63004, Russian Federation
Perm Territorial Oncology Dispensary
Perm , 61406, Russian Federation
SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
St. Petersburg , 19702, Russian Federation
National Cancer Centre
Hospital Drive , 16961, Singapore
Parkway Cancer Centre
Mount Elizabeth , 25850, Singapore
Medical Oncology Centre
Napier Road , 25850, Singapore
John Hopkins Singapore International Medical Centre
Singapore , 30843, Singapore
H Mutua de Terrassa
Barcelona , 08221, Spain
HU Virgen de las Nieves
Granada , 18014, Spain
Fundacion Jimenez Diaz
Madrid , 28040, Spain
HGU La Paz
Madrid , 28046, Spain
Clinica Universitaria de Navarra
Pamplona , 31008, Spain
Changhua Christian Hospital
Changhua , 500, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, , 813, Taiwan
Taichung Veterans General Hospital
Taichung , 403, Taiwan
National Cheng Kung University Hospital
Tainan , 70428, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
Chang-Gung Memorial Hospital, Linkou Branch
Toayuan , 333, Taiwan
Gazi University Medical Faculty
Ankara , 06500, Turkey
Gaziantep University Medical Faculty
Gaziantep , , Turkey
Istanbul Bilim University Medical Fac.
Istanbul , 34394, Turkey
Ege University Medical Faculty
Izmir , 35100, Turkey
Bristol Haematology & Oncology Centre
Bristol Brist, BS2 8, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London Gt Lon, SE1 9, United Kingdom
Christie Hospital
Manchester Gt Man, M20 4, United Kingdom
Southampton General Hospital
Southampton Hants, SO16 , United Kingdom
Castle Hill Hospital
Cottingham Hull Hull, HU16 , United Kingdom
University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
Wythenshawe Manchester, M23 9, United Kingdom
Singleton Hospital
Swansea, S Glam,, SA2 8, United Kingdom
University Hospital of North Staffordshire
Stoke on Trent Staffs, ST4 7, United Kingdom
Wolverhampton New Cross Hospital
Wolverhampton Staffs, WV10 , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow Strath, G12 0, United Kingdom
Ninewells Hospital
Dundee Tays, DD1 9, United Kingdom
University Hospital of Coventry and Warwickshire
Coventry Warwks, CV2 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

742

Study ID:

NCT00707304

Recruitment Status:

Completed

Sponsor:


Agennix

How clear is this clinincal trial information?

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