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.
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
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There are 180 Locations for this study
Casa Grande Arizona, 85122, United States
Tucson Arizona, 85710, United States
Aurora Colorado, 80045, United States
New Port Richey Florida, 34652, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Niles Illinois, 60714, United States
Greenfield Indiana, 46140, United States
Overland Park Kansas, 66210, United States
Bethesda Maryland, 20892, United States
Southfield Michigan, 48075, United States
Minneapolis Minnesota, 55405, United States
St. Louis Missouri, 63128, United States
Lincoln Nebraska, 68510, United States
Hooksett New Hampshire, 03106, United States
Bronx New York, 10467, United States
Rochester New York, 14642, United States
Burlington North Carolina, 27216, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27609, United States
Bismarck North Dakota, 58501, United States
Middletown Ohio, 45042, United States
Portland Oregon, 97227, United States
Dallas Texas, 75230, United States
Fort Worth Texas, 76104, United States
Tyler Texas, 75702, United States
Salem Virginia, 24153, United States
Spokane Washington, 99202, United States
Campbelltown New South Wales, 2560, Australia
Port Macquarie New South Wales, 2444, Australia
Townsville Queensland, 4814, Australia
Woodville South South Australia, 5011, Australia
Richmond Victoria, 3121, Australia
Aleksandur Stamboliyski Plovdiv, 4004, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1527, Bulgaria
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 1, Canada
Lévis Quebec, G6V 3, Canada
Montreal Quebec, H3A 1, Canada
Budinova Praha, 180 0, Czech Republic
Nova Ves pod Plesi , 262 0, Czech Republic
Ostrava , 700 3, Czech Republic
Ostrava , 708 5, Czech Republic
Pardubice , 532 0, Czech Republic
Praha , 100 0, Czech Republic
Praha , 150 0, Czech Republic
Pribram , 261 9, Czech Republic
Tabor , 390 0, Czech Republic
Lille Cedex, 590, France
Rennes Cedex, 35033, France
Saint-herblain Cedex, 44805, France
Strasbourg Cedex, 67085, France
Toulouse Cedex, 31059, France
Eric Tabarly Nantes, 44202, France
Angers cedex , 49933, France
Brest , 29200, France
Caen Cedex , 14076, France
Cedex , 54100, France
Le Mans Cedex , 72037, France
Lyon , 69008, France
Marseille Cedex 9 , 13274, France
Paris , 75012, France
Pierre Bénite Cedex , 69495, France
Reims , 51100, France
Vandoeuvre les Nancy , 54500, France
Freiburg BW, 79106, Germany
Mannheim BW, 68167, Germany
Erlangen BY, 91054, Germany
Gauting BY, 82131, Germany
Muenchen BY, 81675, Germany
Wiesbaden HE, 65191, Germany
Goettingen NI, 37075, Germany
Dortmund NW, 44137, Germany
Woehrendamm SH, 22927, Germany
Halle ST, 06120, Germany
Bad Berka TH, 99437, Germany
Heidelberg , 69126, Germany
Mournies Crete, 73300, Greece
Mezourlo Larissa, 411 1, Greece
Rion Patras, 26505, Greece
Athens , 11527, Greece
Crete , 71110, Greece
Thessaloniki , , Greece
Csabai kapu Miskolc, 3529, Hungary
Seregelyesi Szekesfehervar, 8000, Hungary
Budapest , 1125, Hungary
Budapest , 1529, Hungary
Miskolc , 3526, Hungary
Nyiregyháza , 4412, Hungary
Torokbalint , 2045, Hungary
Zalaegerszeg , 8900, Hungary
Vishakhapattanam Andhhra Pradesh, 53000, India
Hyderabad Andhra Pradesh, 50003, India
Hyderabad Andhra Pradesh, 50003, India
Bangalore Karnataka, 56002, India
Bangalore Karnataka, 56005, India
Mangalore Karnataka, 57500, India
Mumbai Maharashtra, 400 0, India
Mumbai Maharashtra, 40001, India
Mumbai Maharashtra, 40060, India
Nagpur Maharashtra, 44001, India
Nashik Maharashtra, 42200, India
Pune Maharashtra, 411 0, India
Jaipur Rajasthan, 30201, India
Jaipur Rajasthan, 30201, India
Chennai Tamilnadu, 60010, India
Vellore Tamilnadu, 63200, India
Ancona AN, 60020, Italy
Candiolo Candiolo/TO, 10060, Italy
Lido di Camaiore LU, 55043, Italy
Milano MI, 20133, Italy
Monza MI, 20052, Italy
Roma, RM, , Italy
Legnago VR, 37045, Italy
Aviano , 33081, Italy
Cremona , 26100, Italy
Hwasun up Chonnam, 519-8, Korea, Republic of
Ilsandong-gu Goyang, 411-7, Korea, Republic of
Seongnam-si Gyeonggi-do,, 463-7, Korea, Republic of
Gangnam-Gu Seoul, 135-7, Korea, Republic of
Jongno-gu Seoul, 110-7, Korea, Republic of
Seongbuk-gu Seoul, 136-7, Korea, Republic of
Songpa-gu Seoul, 138-7, Korea, Republic of
Paldal-gu Suwon Gyeonggi-do, 442-7, Korea, Republic of
Daugavpils , LV-54, Latvia
Liepaja , LV-43, Latvia
Riga , LV-10, Latvia
Riga , LV100, Latvia
Negeri Sembilan Darul Khusus, 71800, Malaysia
Pulau Pinang Georgetown,, 11600, Malaysia
Kubang Kerian Kelantan, 16150, Malaysia
Kuantan Pahang, 25100, Malaysia
Manila , 1000, Philippines
Quezon City , 1100, Philippines
Quezon City , 1102, Philippines
Gdansk , 80-95, Poland
Krakow , 31-10, Poland
Lubin , 59-30, Poland
Olsztyn , 10-51, Poland
Szczecin , 70-89, Poland
Warszawa , 02-78, Poland
Str. Republicii nr. 34-36 Cluj-Napoca, 40001, Romania
Baia Mare , 43003, Romania
Braila , 81032, Romania
Bucuresti , 02096, Romania
Cluj-Napoca , 40001, Romania
Suceava , 72023, Romania
Dagomysskaya str. Sochi, 35405, Russian Federation
Arkhangelsk , 16304, Russian Federation
Barnaul , 65605, Russian Federation
Moscow , 12912, Russian Federation
Novosibirsk , 63004, Russian Federation
Perm , 61406, Russian Federation
St. Petersburg , 19702, Russian Federation
Hospital Drive , 16961, Singapore
Mount Elizabeth , 25850, Singapore
Napier Road , 25850, Singapore
Singapore , 30843, Singapore
Barcelona , 08221, Spain
Granada , 18014, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
Changhua , 500, Taiwan
Kaohsiung, , 813, Taiwan
Taichung , 403, Taiwan
Tainan , 70428, Taiwan
Taipei , 112, Taiwan
Toayuan , 333, Taiwan
Ankara , 06500, Turkey
Gaziantep , , Turkey
Istanbul , 34394, Turkey
Izmir , 35100, Turkey
Bristol Brist, BS2 8, United Kingdom
London Gt Lon, SE1 9, United Kingdom
Manchester Gt Man, M20 4, United Kingdom
Southampton Hants, SO16 , United Kingdom
Cottingham Hull Hull, HU16 , United Kingdom
Wythenshawe Manchester, M23 9, United Kingdom
Swansea, S Glam,, SA2 8, United Kingdom
Stoke on Trent Staffs, ST4 7, United Kingdom
Wolverhampton Staffs, WV10 , United Kingdom
Glasgow Strath, G12 0, United Kingdom
Dundee Tays, DD1 9, United Kingdom
Coventry Warwks, CV2 2, United Kingdom
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