Non Small Cell Lung Cancer Clinical Trial
— FORTIS-MOfficial title:
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
Verified date | August 2012 |
Source | Agennix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 742 |
Est. completion date | August 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Campbelltown Hospital | Campbelltown | New South Wales |
Australia | Port Macquarie Base Hospital | Port Macquarie | New South Wales |
Australia | Epworth Healthcare | Richmond | Victoria |
Australia | Townsville Hospital | Townsville | Queensland |
Australia | The Queen Elisabeth Hospital | Woodville South | South Australia |
Bulgaria | DDODIU-Plovdiv, EOOD | Aleksandur Stamboliyski | Plovdiv |
Bulgaria | UMHAT 'Dr. Georgi Stranski', EAD | Pleven | |
Bulgaria | DDODIU-Plovdiv, EOOD | Plovdiv | |
Bulgaria | DDODIU - Sofia District EOOD | Sofia | |
Bulgaria | UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Sofia | |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Hôtel-Dieu de Lévis | Lévis | Quebec |
Canada | Gerald Bronfman Centre for Clinical Research in Oncology | Montreal | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Czech Republic | Fakultni nemocnice Na Bulovce | Budinova | Praha |
Czech Republic | Institut Onkologie a Rehabilitace Na Plesi | Nova Ves pod Plesi | |
Czech Republic | Fakultni Nemocnice Ostrava | Ostrava | |
Czech Republic | Vitkovicka nemocnice a.s. | Ostrava | |
Czech Republic | Pardubicka krajska nemocnice, a.s. | Pardubice | |
Czech Republic | Fakultni Nemocnice Kralovske Vinohrady | Praha | |
Czech Republic | Fakultni nemocnice v Motole, s.p. | Praha | |
Czech Republic | Oblastni nemocnice Pribram, a.s. | Pribram | |
Czech Republic | Nemocnice Tabor, a.s. | Tabor | |
France | CHU Angers | Angers cedex | |
France | Hopital Morvan | Brest | |
France | Centre Francois Baclesse | Caen Cedex | |
France | Centre d'Oncology de Gentilly | Cedex | |
France | Centre Catherine de Sienne | Eric Tabarly | Nantes |
France | Centre Hospitalier du Mans | Le Mans Cedex | |
France | Hopital Cardiologique, Chru Lille | Lille | Cedex |
France | Centre Léon Berard | Lyon | |
France | Hopital Sainte Marguerite | Marseille Cedex 9 | |
France | Hôpital Saint-Antoine | Paris | |
France | Centre Hospitalier Lyon Sud | Pierre Bénite Cedex | |
France | Hopital Maison Blanche | Reims | |
France | CHU Pontchaillou | Rennes | Cedex |
France | CRLCC René Gauducheau | Saint-herblain | Cedex |
France | CLCC Paul Strauss | Strasbourg | Cedex |
France | Hopital Larrey | Toulouse | Cedex |
France | CHU de Nancy, Hopital de Brabois | Vandoeuvre les Nancy | |
Germany | Zentralklinik Bad Berka | Bad Berka | TH |
Germany | St. Johannes Hospital - PS | Dortmund | NW |
Germany | Universitaetsklinikum Erlangen - PS | Erlangen | BY |
Germany | Praxis fuer interdisziplinaere Onkologie | Freiburg | BW |
Germany | Asklepios Fachkliniken Muenchen-Gauting | Gauting | BY |
Germany | Universitaetsklinikum Goettingen | Goettingen | NI |
Germany | Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH | Halle | ST |
Germany | Thoraxklinik-Heidelberg gGmbH | Heidelberg | |
Germany | Universitaetsklinikum Mannheim | Mannheim | BW |
Germany | Klinikum rechts der Isar der TU Muenchen | Muenchen | BY |
Germany | Gemeinschaftspraxis fuer Haematologie Onkologie | Wiesbaden | HE |
Germany | Krankenhaus Grosshansdorf | Woehrendamm | SH |
Greece | General Hospital of Athens "Sotiria" | Athens | |
Greece | University Hospital of Heraklio | Crete | |
Greece | University Hospital of Larissa | Mezourlo | Larissa |
Greece | General Hospital of Chania 'Ag. Georgios' | Mournies | Crete |
Greece | University General Hospital of Patras | Rion | Patras |
Greece | General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki | |
Hungary | Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi | Csabai kapu | Miskolc |
Hungary | Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Miskolc | |
Hungary | Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz | Nyiregyháza | |
Hungary | Fejer Megyei Szent Gyorgy Korhaz | Seregelyesi | Szekesfehervar |
Hungary | Torokbalinti Tudogyogyintezet | Torokbalint | |
Hungary | Zala Megyei Korhaz | Zalaegerszeg | |
India | Kidwai Institute of Oncology | Bangalore | Karnataka |
India | M. S. Ramaiah Memorial Hospital | Bangalore | Karnataka |
India | Dr. Kamakshi Memorial Hospital Pvt Ltd | Chennai | Tamilnadu |
India | Apollo Hospital | Hyderabad | Andhra Pradesh |
India | Indo-American Cancer Institute and Research Center | Hyderabad | Andhra Pradesh |
India | Mahaveer Cancer Hospital and Research Centre | Jaipur | Rajasthan |
India | Searoc Cancer Hospital | Jaipur | Rajasthan |
India | A.J. Medical College Hosptial | Mangalore | Karnataka |
India | Kaushalya Medical Foundation Trust Hospital | Mumbai | Maharashtra |
India | P.D. Hinduja Nat. Hospital & Med. Research Centre | Mumbai | Maharashtra |
India | Tata Memorial Hospital | Mumbai | Maharashtra |
India | Cancer Care Clinic | Nagpur | Maharashtra |
India | Shatabdi Hospital | Nashik | Maharashtra |
India | Deenanath Mangeshkar Hospital and Research Center | Pune | Maharashtra |
India | Christian Medical College Hospital | Vellore | Tamilnadu |
India | King George Hospital | Vishakhapattanam | Andhhra Pradesh |
Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I | Ancona | AN |
Italy | CRO Centro di Riferimento Oncologico di Aviano | Aviano | |
Italy | Istituto per la Ricerca e la Cura del Cancro | Candiolo | Candiolo/TO |
Italy | Azienda Ospedaliera Istituti Ospitalieri di Cremona | Cremona | |
Italy | Ospedale Mater Salutis | Legnago | VR |
Italy | Ospedale Versilia | Lido di Camaiore | LU |
Italy | Istituto Nazionale Tumori | Milano | MI |
Italy | Azienda Ospedaliera San Gerardo | Monza | MI |
Italy | Azienda Ospedaliera San Camillo Forlanini | Roma, | RM |
Korea, Republic of | Samsung Medical Center | Gangnam-Gu | Seoul |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun up | Chonnam |
Korea, Republic of | National Cancer Center | Ilsandong-gu | Goyang |
Korea, Republic of | Seoul National University Hospital | Jongno-gu | Seoul |
Korea, Republic of | The Catholic University of Korea St. Vincent's Hospital | Paldal-gu | Suwon Gyeonggi-do |
Korea, Republic of | Korea University Anam Hospital | Seongbuk-gu | Seoul |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do, |
Korea, Republic of | Asan Medical Center | Songpa-gu | Seoul |
Latvia | Dr. Anna Levcenko GP and Internist Practice | Daugavpils | |
Latvia | Piejuras Hospital | Liepaja | |
Latvia | P. Stradina Clinical University Hospital | Riga | |
Latvia | Riga Eastern Clinical University Hospital | Riga | |
Malaysia | Hospital Tengku Ampuan Afzan | Kuantan | Pahang |
Malaysia | Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Malaysia | Nilai Cancer Institute (NCI Cancer Hospital) | Negeri Sembilan | Darul Khusus |
Malaysia | Lam Wah Ee Hospital | Pulau Pinang | Georgetown, |
Philippines | Manila Doctors Hospital | Manila | |
Philippines | Lung Center of the Philippines | Quezon City | |
Philippines | St. Luke's Medical Center | Quezon City | |
Poland | Akademickie Centrum Kliniczne - Szpital AM w Gdansku | Gdansk | |
Poland | Nzoz Vesalius | Krakow | |
Poland | Miedziowe Centrum Zdrowia S.A. | Lubin | |
Poland | NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o | Olsztyn | |
Poland | Specjalistyczny Szpital im. Prof. A. Sokolowskiego | Szczecin | |
Poland | Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warszawa | |
Romania | Spitalul Judetean de Urgenta "Dr. Constantin Opris" | Baia Mare | |
Romania | Spitalul Judetean de Urgenta Braila | Braila | |
Romania | S.C. Ianuli Med Consult S.R.L. | Bucuresti | |
Romania | Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca | Cluj-Napoca | |
Romania | Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca | Str. Republicii nr. 34-36 | Cluj-Napoca |
Romania | Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava | Suceava | |
Russian Federation | Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | |
Russian Federation | SHI Altay Regional Oncology Dispensary | Barnaul | |
Russian Federation | Oncology Dispensary #2 of Krasnodar Region | Dagomysskaya str. | Sochi |
Russian Federation | CCH #2 n.a. N. A. Semashko of LLC "Russian Railways" | Moscow | |
Russian Federation | City Clinical Hospital #1 | Novosibirsk | |
Russian Federation | Perm Territorial Oncology Dispensary | Perm | |
Russian Federation | SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov" | St. Petersburg | |
Singapore | National Cancer Centre | Hospital Drive | |
Singapore | Parkway Cancer Centre | Mount Elizabeth | |
Singapore | Medical Oncology Centre | Napier Road | |
Singapore | John Hopkins Singapore International Medical Centre | Singapore | |
Spain | H Mutua de Terrassa | Barcelona | |
Spain | HU Virgen de las Nieves | Granada | |
Spain | Fundacion Jimenez Diaz | Madrid | |
Spain | HGU La Paz | Madrid | |
Spain | Clinica Universitaria de Navarra | Pamplona | |
Taiwan | Changhua Christian Hospital | Changhua | |
Taiwan | Kaohsiung Veterans General Hospital | Kaohsiung, | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Chang-Gung Memorial Hospital, Linkou Branch | Toayuan | |
Turkey | Gazi University Medical Faculty | Ankara | |
Turkey | Gaziantep University Medical Faculty | Gaziantep | |
Turkey | Istanbul Bilim University Medical Fac. | Istanbul | |
Turkey | Ege University Medical Faculty | Izmir | |
United Kingdom | Bristol Haematology & Oncology Centre | Bristol | Brist |
United Kingdom | Castle Hill Hospital | Cottingham Hull | Hull |
United Kingdom | University Hospital of Coventry and Warwickshire | Coventry | Warwks |
United Kingdom | Ninewells Hospital | Dundee | Tays |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Strath |
United Kingdom | Guy's & St Thomas' NHS Foundation Trust | London | Gt Lon |
United Kingdom | Christie Hospital | Manchester | Gt Man |
United Kingdom | Southampton General Hospital | Southampton | Hants |
United Kingdom | University Hospital of North Staffordshire | Stoke on Trent | Staffs |
United Kingdom | Singleton Hospital | Swansea, | S Glam, |
United Kingdom | Wolverhampton New Cross Hospital | Wolverhampton | Staffs |
United Kingdom | University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital | Wythenshawe | Manchester |
United States | Emory University | Atlanta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | NCI, CCR, The Waren Grant Magnuson Clinical Center | Bethesda | Maryland |
United States | Legacy Pharma Research | Bismarck | North Dakota |
United States | Montefiore Medical Center | Bronx | New York |
United States | Alamance Regional Medical Center | Burlington | North Carolina |
United States | Desert Oasis Cancer Center | Casa Grande | Arizona |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Texas Oncology | Dallas | Texas |
United States | Cancer Care Specialists of Central Illinois | Decatur | Illinois |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Texas Oncology | Fort Worth | Texas |
United States | Central Indiana Cancer Centers | Greenfield | Indiana |
United States | NH Oncology-Hematology, PA | Hooksett | New Hampshire |
United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
United States | Signal Point Clinical Research Center | Middletown | Ohio |
United States | Minnesota Oncology and Hematology, PA | Minneapolis | Minnesota |
United States | Pasco Pinellas Cancer Center | New Port Richey | Florida |
United States | Cancer Care & Hematology Specialists of Chicagoland | Niles | Illinois |
United States | Kansas City Cancer Center, LLC | Overland Park | Kansas |
United States | Kaiser Group Health | Portland | Oregon |
United States | Rex Cancer Center | Raleigh | North Carolina |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Salem | Virginia |
United States | Newland Medical Associates | Southfield | Michigan |
United States | Cancer Care Northwest | Spokane | Washington |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Arizona Oncology Associates | Tucson | Arizona |
United States | Tyler Cancer Center | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Agennix |
United States, Australia, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Latvia, Malaysia, Philippines, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | After the occurence of the required number of events | No | |
Secondary | Progression free survival | At time of final analysis | No | |
Secondary | Objective response and disease stablization rate | At time of final analysis | No | |
Secondary | Safety and tolerability | At time of final analysis | Yes |
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