Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
FORTIS-M
FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
1 other identifier
interventional
742
23 countries
189
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2008
Typical duration for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 21, 2012
August 1, 2012
2.3 years
June 26, 2008
August 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
After the occurence of the required number of events
Secondary Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTALTalactoferrin 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.
2
PLACEBO COMPARATORPlacebo 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.
Interventions
Oral, 1.5 grams twice per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agennixlead
Study Sites (189)
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
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, 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
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Pleven, 5800, Bulgaria
DDODIU-Plovdiv, EOOD
Aleksandur Stamboliyski, Plovdiv, 4004, Bulgaria
DDODIU-Plovdiv, EOOD
Plovdiv, Plovdiv, 4004, Bulgaria
DDODIU - Sofia District EOOD
Sofia, 1233, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1, Canada
Gerald Bronfman Centre for Clinical Research in Oncology
Montreal, Quebec, H3A 1A1, Canada
Pardubicka krajska nemocnice, a.s.
Pardubice, Pardubice, 532 03, Czechia
Fakultni nemocnice Na Bulovce
Budinova, Prague, 180 00, Czechia
Oblastni nemocnice Pribram, a.s.
Příbram, Pribram, 261 95, Czechia
Institut Onkologie a Rehabilitace Na Plesi
Nová Ves pod Pleší, 262 04, Czechia
Vitkovicka nemocnice a.s.
Ostrava, 700 30, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 52, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, 100 00, Czechia
Fakultni nemocnice v Motole, s.p.
Prague, 150 06, Czechia
Nemocnice Tabor, a.s.
Tábor, 390 03, Czechia
CHU Angers
Angers, Angers Cedex, 49933, France
Centre Francois Baclesse
Caen, Caen Cedex, 14076, France
Centre d'Oncology de Gentilly
Cedex, Cedex, 54100, France
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 Hospitalier du Mans
Le Mans, Le Mans Cedex, 72037, France
Centre Léon Berard
Lyon, Lyon, 69008, France
Centre Catherine de Sienne
Eric Tabarly, Nantes, 44202, France
Hôpital Saint-Antoine
Paris, Paris, 75012, France
Hopital Maison Blanche
Reims, Reims, 51100, France
CHU de Nancy, Hopital de Brabois
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500, France
Hopital Morvan
Brest, 29200, France
Hopital Sainte Marguerite
Marseille, 13274, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Praxis fuer interdisziplinaere Onkologie
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Erlangen - PS
Erlangen, Bavaria, 91054, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Bavaria, 82131, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Heidelberg, 69126, Germany
Gemeinschaftspraxis fuer Haematologie Onkologie
Wiesbaden, Hesse, 65191, Germany
Universitaetsklinikum Goettingen
Göttingen, Lower Saxony, 37075, Germany
St. Johannes Hospital - PS
Dortmund, North Rhine-Westphalia, 44137, Germany
Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Saxony-Anhalt, 06120, Germany
Krankenhaus Grosshansdorf
Woehrendamm, Schleswig-Holstein, 22927, Germany
Zentralklinik Bad Berka
Bad Berka, Thuringia, 99437, Germany
General Hospital of Athens "Sotiria"
Athens, Athens, 11527, Greece
University Hospital of Heraklio
Crete, Crete, 71110, Greece
General Hospital of Chania 'Ag. Georgios'
Mourniés, Crete, 73300, Greece
University Hospital of Larissa
Mezourlo, Larissa, 411 10, Greece
University General Hospital of Patras
Rio, Patras, 26505, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece
Semmelweis Egyetem
Budapest, Budapest, 1125, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, Budapest, 1529, Hungary
Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
Csabai Kapu, Miskolc, 3529, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Miskolc, 3526, Hungary
Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
Nyiregyháza, Nyiregyháza, 4412, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Seregelyesi, Szekesfehervar, 8000, Hungary
Torokbalinti Tudogyogyintezet
Törökbálint, Torokbalint, 2045, Hungary
Zala Megyei Korhaz
Zalaegerszeg, Zalaegerszeg, 8900, Hungary
King George Hospital
Vishakhapattanam, Andhhra Pradesh, 530002, India
Apollo Hospital
Hyderabad, Andhra Pradesh, 500033, India
Indo-American Cancer Institute and Research Center
Hyderabad, Andhra Pradesh, 500034, India
Kidwai Institute of Oncology
Bangalore, Karnataka, 560029, India
M. S. Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054, India
A.J. Medical College Hosptial
Mangalore, Karnataka, 575001, India
Tata Memorial Hospital
Mumbai, Maharashtra, 400 012, India
P.D. Hinduja Nat. Hospital & Med. Research Centre
Mumbai, Maharashtra, 400016, India
Kaushalya Medical Foundation Trust Hospital
Mumbai, Maharashtra, 400601, India
Cancer Care Clinic
Nagpur, Maharashtra, 440012, India
Shatabdi Hospital
Nashik, Maharashtra, 422005, India
Deenanath Mangeshkar Hospital and Research Center
Pune, Maharashtra, 411 004, India
Searoc Cancer Hospital
Jaipur, Rajasthan, 302013, India
Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, 302017, India
Dr. Kamakshi Memorial Hospital Pvt Ltd
Chennai, Tamil Nadu, 600100, India
Christian Medical College Hospital
Vellore, Tamil Nadu, 632002, India
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona, AN, 60020, Italy
CRO Centro di Riferimento Oncologico di Aviano
Aviano, Aviano, 33081, Italy
Istituto per la Ricerca e la Cura del Cancro
Candiolo, Candiolo/TO, 10060, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, Cremona, 26100, Italy
Ospedale Versilia
Lido di Camaiore, LU, 55043, Italy
Istituto Nazionale Tumori
Milan, 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
Dr. Anna Levcenko GP and Internist Practice
Daugavpils, LV-5403, Latvia
Piejuras Hospital
Liepāja, LV-4301, Latvia
Riga Eastern Clinical University Hospital
Riga, LV-1079, Latvia
P. Stradina Clinical University Hospital
Riga, LV1002, 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
St. Luke's Medical Center
Quezon City, Quezon City, 1102, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
Lung Center of the Philippines
Quezon City, 1100, Philippines
Akademickie Centrum Kliniczne - Szpital AM w Gdansku
Gdansk, Gdansk, 80-952, Poland
Nzoz Vesalius
Krakow, Krakow, 31-108, Poland
Miedziowe Centrum Zdrowia S.A.
Lubin, Lubin, 59-301, Poland
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
Olsztyn, Olsztyn, 10-513, Poland
Specjalistyczny Szpital im. Prof. A. Sokolowskiego
Szczecin, Szczecin, 70-891, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, Warszawa, 02-781, Poland
Spitalul Judetean de Urgenta Braila
Brăila, Brăila County, 810325, Romania
S.C. Ianuli Med Consult S.R.L.
Bucharest, București, 020962, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Str. Republicii Nr. 34-36, Cluj-Napoca, 400015, Romania
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
Suceava, Suceava, 720237, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
Baia Mare, 430031, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, 400015, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
SHI Altay Regional Oncology Dispensary
Barnaul, Barnaul, 656052, Russia
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
Moscow, Moscow, 129128, Russia
City Clinical Hospital #1
Novosibirsk, Novosibirsk Oblast, 630047, Russia
Perm Territorial Oncology Dispensary
Perm, Perm Krai, 614066, Russia
SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
Saint Petersburg, Sankt-Peterburg, 197022, Russia
Oncology Dispensary #2 of Krasnodar Region
Dagomysskaya Str., Sochi, 354057, Russia
National Cancer Centre
Hospital Drive, Singapore, 169610, Singapore
Parkway Cancer Centre
Mount Elizabeth, Singapore, 258500, Singapore
Medical Oncology Centre
Napier Road, Singapore, 258500, Singapore
John Hopkins Singapore International Medical Centre
Singapore, 308433, Singapore
Chonnam National University Hwasun Hospital
Hwasun Up, Chonnam, 519-809, South Korea
National Cancer Center
Ilsandong-gu, Goyang, 411-769, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Samsung Medical Center
Gangnam-Gu, Seoul, 135-710, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, 110-744, South Korea
Korea University Anam Hospital
Seongbuk-gu, Seoul, 136-705, South Korea
Asan Medical Center
Songpa-gu, Seoul, 138-736, South Korea
The Catholic University of Korea St. Vincent's Hospital
Paldal-gu, Suwon Gyeonggi-do, 442-723, South Korea
H Mutua de Terrassa
Barcelona, Barcelona, 08221, Spain
HU Virgen de las Nieves
Granada, Granada, 18014, Spain
Fundacion Jimenez Diaz
Madrid, Madrid, 28040, Spain
HGU La Paz
Madrid, Madrid, 28046, Spain
Clinica Universitaria de Navarra
Pamplona, Pamplona, 31008, Spain
Changhua Christian Hospital
Changhua, Changhua, 500, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813, Taiwan
Taichung Veterans General Hospital
Taichung, Taichung, 403, Taiwan
National Cheng Kung University Hospital
Tainan, Tainan, 70428, Taiwan
Taipei Veterans General Hospital
Taipei, Taipei, 112, Taiwan
Chang-Gung Memorial Hospital, Linkou Branch
Toayuan, Toayuan, 333, Taiwan
Gazi University Medical Faculty
Ankara, Ankara, 06500, Turkey (Türkiye)
Gaziantep University Medical Faculty
Gaziantep, Gaziantep, Turkey (Türkiye)
Istanbul Bilim University Medical Fac.
Istanbul, 34394, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Bristol Haematology & Oncology Centre
Bristol, Brist, BS2 8ED, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, Gt Lon, SE1 9RT, United Kingdom
Christie Hospital
Manchester, Gt Man, M20 4BX, United Kingdom
Southampton General Hospital
Southampton, Hants, SO16 6YD, United Kingdom
Castle Hill Hospital
Cottingham Hull, Hull, HU16 5JQ, United Kingdom
University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT, United Kingdom
Singleton Hospital
Swansea, S Glam,, SA2 8QA, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, Staffs, ST4 7LN, United Kingdom
Wolverhampton New Cross Hospital
Wolverhampton, Staffs, WV10 0QP, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Strath, G12 0YN, United Kingdom
Ninewells Hospital
Dundee, Tays, DD1 9SY, United Kingdom
University Hospital of Coventry and Warwickshire
Coventry, Warwks, CV2 2DX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
November 1, 2008
Primary Completion
March 1, 2011
Study Completion
August 1, 2012
Last Updated
August 21, 2012
Record last verified: 2012-08