Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
- Registration Number
- NCT00707304
- Lead Sponsor
- Agennix
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 742
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD\&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product. 1 Talactoferrin Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.
- Primary Outcome Measures
Name Time Method Overall survival After the occurence of the required number of events
- Secondary Outcome Measures
Name Time Method Progression free survival At time of final analysis Objective response and disease stablization rate At time of final analysis Safety and tolerability At time of final analysis
Trial Locations
- Locations (186)
Kaushalya Medical Foundation Trust Hospital
🇮🇳Mumbai, Maharashtra, India
Legacy Pharma Research
🇺🇸Bismarck, North Dakota, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University General Hospital of Patras
🇬🇷Rion, Patras, Greece
General Hospital of Athens "Sotiria"
🇬🇷Athens, Greece
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Medical Oncology Centre
🇸🇬Napier Road, Singapore
Kansas City Cancer Center, LLC
🇺🇸Overland Park, Kansas, United States
Alamance Regional Medical Center
🇺🇸Burlington, North Carolina, United States
NCI, CCR, The Waren Grant Magnuson Clinical Center
🇺🇸Bethesda, Maryland, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Pasco Pinellas Cancer Center
🇺🇸New Port Richey, Florida, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
UMHAT 'Dr. Georgi Stranski', EAD
🇧🇬Pleven, Bulgaria
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Cancer Care & Hematology Specialists of Chicagoland
🇺🇸Niles, Illinois, United States
University Hospital of Larissa
🇬🇷Mezourlo, Larissa, Greece
Kaiser Group Health
🇺🇸Portland, Oregon, United States
Pardubicka krajska nemocnice, a.s.
🇨🇿Pardubice, Czech Republic
Asklepios Fachkliniken Muenchen-Gauting
🇩🇪Gauting, BY, Germany
Cancer Care Specialists of Central Illinois
🇺🇸Decatur, Illinois, United States
Centre Catherine de Sienne
🇫🇷Eric Tabarly, Nantes, France
Epworth Healthcare
🇦🇺Richmond, Victoria, Australia
Shatabdi Hospital
🇮🇳Nashik, Maharashtra, India
University Hospital of Heraklio
🇬🇷Crete, Greece
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Searoc Cancer Hospital
🇮🇳Jaipur, Rajasthan, India
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
DDODIU - Sofia District EOOD
🇧🇬Sofia, Bulgaria
Oblastni nemocnice Pribram, a.s.
🇨🇿Pribram, Czech Republic
Zentralklinik Bad Berka
🇩🇪Bad Berka, TH, Germany
King George Hospital
🇮🇳Vishakhapattanam, Andhhra Pradesh, India
DDODIU-Plovdiv, EOOD
🇧🇬Plovdiv, Bulgaria
Nemocnice Tabor, a.s.
🇨🇿Tabor, Czech Republic
The Queen Elisabeth Hospital
🇦🇺Woodville South, South Australia, Australia
St. Johannes Hospital - PS
🇩🇪Dortmund, NW, Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet
🇭🇺Budapest, Hungary
Signal Point Clinical Research Center
🇺🇸Middletown, Ohio, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
🇺🇸Salem, Virginia, United States
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Na Bulovce
🇨🇿Budinova, Praha, Czech Republic
Krankenhaus Grosshansdorf
🇩🇪Woehrendamm, SH, Germany
Texas Oncology
🇺🇸Fort Worth, Texas, United States
Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle, ST, Germany
General Hospital of Chania 'Ag. Georgios'
🇬🇷Mournies, Crete, Greece
Indo-American Cancer Institute and Research Center
🇮🇳Hyderabad, Andhra Pradesh, India
Thoraxklinik-Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Klinikum rechts der Isar der TU Muenchen
🇩🇪Muenchen, BY, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, NI, Germany
Universitaetsklinikum Erlangen - PS
🇩🇪Erlangen, BY, Germany
Seoul National University Hospital
🇰🇷Jongno-gu, Seoul, Korea, Republic of
Istituto Nazionale Tumori
🇮🇹Milano, MI, Italy
Cancer Care Clinic
🇮🇳Nagpur, Maharashtra, India
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma,, RM, Italy
Ospedale Mater Salutis
🇮🇹Legnago, VR, Italy
Oncology Dispensary #2 of Krasnodar Region
🇷🇺Dagomysskaya str., Sochi, Russian Federation
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Istanbul Bilim University Medical Fac.
🇹🇷Istanbul, Turkey
H Mutua de Terrassa
🇪🇸Barcelona, Spain
HGU La Paz
🇪🇸Madrid, Spain
S.C. Ianuli Med Consult S.R.L.
🇷🇴Bucuresti, Romania
Azienda Ospedaliera San Gerardo
🇮🇹Monza, MI, Italy
City Clinical Hospital #1
🇷🇺Novosibirsk, Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
🇷🇺Arkhangelsk, Russian Federation
Chang-Gung Memorial Hospital, Linkou Branch
🇨🇳Toayuan, Taiwan
John Hopkins Singapore International Medical Centre
🇸🇬Singapore, Singapore
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Christie Hospital
🇬🇧Manchester, Gt Man, United Kingdom
Mahaveer Cancer Hospital and Research Centre
🇮🇳Jaipur, Rajasthan, India
University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
🇬🇧Wythenshawe, Manchester, United Kingdom
Minnesota Oncology and Hematology, PA
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
Zala Megyei Korhaz
🇭🇺Zalaegerszeg, Hungary
Manila Doctors Hospital
🇵🇭Manila, Philippines
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
🇵🇱Olsztyn, Poland
Dr. Kamakshi Memorial Hospital Pvt Ltd
🇮🇳Chennai, Tamilnadu, India
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha, Czech Republic
Kidwai Institute of Oncology
🇮🇳Bangalore, Karnataka, India
Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
🇭🇺Csabai kapu, Miskolc, Hungary
Institut Onkologie a Rehabilitace Na Plesi
🇨🇿Nova Ves pod Plesi, Czech Republic
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
🇭🇺Nyiregyháza, Hungary
M. S. Ramaiah Memorial Hospital
🇮🇳Bangalore, Karnataka, India
Dr. Anna Levcenko GP and Internist Practice
🇱🇻Daugavpils, Latvia
Miedziowe Centrum Zdrowia S.A.
🇵🇱Lubin, Poland
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
🇷🇴Baia Mare, Romania
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
🇷🇴Suceava, Romania
National Cancer Centre
🇸🇬Hospital Drive, Singapore
Vitkovicka nemocnice a.s.
🇨🇿Ostrava, Czech Republic
Torokbalinti Tudogyogyintezet
🇭🇺Torokbalint, Hungary
Apollo Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Lam Wah Ee Hospital
🇲🇾Pulau Pinang, Georgetown,, Malaysia
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Spitalul Judetean de Urgenta Braila
🇷🇴Braila, Romania
Semmelweis Egyetem
🇭🇺Budapest, Hungary
P.D. Hinduja Nat. Hospital & Med. Research Centre
🇮🇳Mumbai, Maharashtra, India
Christian Medical College Hospital
🇮🇳Vellore, Tamilnadu, India
Nilai Cancer Institute (NCI Cancer Hospital)
🇲🇾Negeri Sembilan, Darul Khusus, Malaysia
A.J. Medical College Hosptial
🇮🇳Mangalore, Karnataka, India
Deenanath Mangeshkar Hospital and Research Center
🇮🇳Pune, Maharashtra, India
Akademickie Centrum Kliniczne - Szpital AM w Gdansku
🇵🇱Gdansk, Poland
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung,, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Hopital Morvan
🇫🇷Brest, France
Gemeinschaftspraxis fuer Haematologie Onkologie
🇩🇪Wiesbaden, HE, Germany
Perm Territorial Oncology Dispensary
🇷🇺Perm, Russian Federation
SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
🇷🇺St. Petersburg, Russian Federation
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
Centre Hospitalier du Mans
🇫🇷Le Mans Cedex, France
Hopital Maison Blanche
🇫🇷Reims, France
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Desert Oasis Cancer Center
🇺🇸Casa Grande, Arizona, United States
Central Indiana Cancer Centers
🇺🇸Greenfield, Indiana, United States
Newland Medical Associates
🇺🇸Southfield, Michigan, United States
NH Oncology-Hematology, PA
🇺🇸Hooksett, New Hampshire, United States
Townsville Hospital
🇦🇺Townsville, Queensland, Australia
Rex Cancer Center
🇺🇸Raleigh, North Carolina, United States
Hôtel-Dieu de Lévis
🇨🇦Lévis, Quebec, Canada
Gerald Bronfman Centre for Clinical Research in Oncology
🇨🇦Montreal, Quebec, Canada
Fakultni nemocnice v Motole, s.p.
🇨🇿Praha, Czech Republic
Fakultni Nemocnice Ostrava
🇨🇿Ostrava, Czech Republic
Hopital Cardiologique, Chru Lille
🇫🇷Lille, Cedex, France
CHU Pontchaillou
🇫🇷Rennes, Cedex, France
CLCC Paul Strauss
🇫🇷Strasbourg, Cedex, France
Hopital Larrey
🇫🇷Toulouse, Cedex, France
CRLCC René Gauducheau
🇫🇷Saint-herblain, Cedex, France
CHU Angers
🇫🇷Angers cedex, France
Centre Francois Baclesse
🇫🇷Caen Cedex, France
Centre d'Oncology de Gentilly
🇫🇷Cedex, France
Centre Léon Berard
🇫🇷Lyon, France
Hôpital Saint-Antoine
🇫🇷Paris, France
Universitaetsklinikum Mannheim
🇩🇪Mannheim, BW, Germany
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Hopital Sainte Marguerite
🇫🇷Marseille Cedex 9, France
Praxis fuer interdisziplinaere Onkologie
🇩🇪Freiburg, BW, Germany
CHU de Nancy, Hopital de Brabois
🇫🇷Vandoeuvre les Nancy, France
Fejer Megyei Szent Gyorgy Korhaz
🇭🇺Seregelyesi, Szekesfehervar, Hungary
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
🇮🇹Ancona, AN, Italy
Istituto per la Ricerca e la Cura del Cancro
🇮🇹Candiolo, Candiolo/TO, Italy
Ospedale Versilia
🇮🇹Lido di Camaiore, LU, Italy
CRO Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
🇮🇹Cremona, Italy
National Cancer Center
🇰🇷Ilsandong-gu, Goyang, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun up, Chonnam, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do,, Korea, Republic of
Samsung Medical Center
🇰🇷Gangnam-Gu, Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seongbuk-gu, Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Songpa-gu, Seoul, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Paldal-gu, Suwon Gyeonggi-do, Korea, Republic of
Piejuras Hospital
🇱🇻Liepaja, Latvia
Riga Eastern Clinical University Hospital
🇱🇻Riga, Latvia
P. Stradina Clinical University Hospital
🇱🇻Riga, Latvia
Hospital Universiti Sains Malaysia
🇲🇾Kubang Kerian, Kelantan, Malaysia
Lung Center of the Philippines
🇵🇭Quezon City, Philippines
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Nzoz Vesalius
🇵🇱Krakow, Poland
Specjalistyczny Szpital im. Prof. A. Sokolowskiego
🇵🇱Szczecin, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
🇵🇱Warszawa, Poland
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
🇷🇺Moscow, Russian Federation
SHI Altay Regional Oncology Dispensary
🇷🇺Barnaul, Russian Federation
Parkway Cancer Centre
🇸🇬Mount Elizabeth, Singapore
HU Virgen de las Nieves
🇪🇸Granada, Spain
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Gaziantep University Medical Faculty
🇹🇷Gaziantep, Turkey
Guy's & St Thomas' NHS Foundation Trust
🇬🇧London, Gt Lon, United Kingdom
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Bristol Haematology & Oncology Centre
🇬🇧Bristol, Brist, United Kingdom
Singleton Hospital
🇬🇧Swansea,, S Glam,, United Kingdom
Southampton General Hospital
🇬🇧Southampton, Hants, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke on Trent, Staffs, United Kingdom
Wolverhampton New Cross Hospital
🇬🇧Wolverhampton, Staffs, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Strath, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Tays, United Kingdom
University Hospital of Coventry and Warwickshire
🇬🇧Coventry, Warwks, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Castle Hill Hospital
🇬🇧Cottingham Hull, Hull, United Kingdom