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

Non Small Cell Lung Cancer Clinical Trial

— FORTIS-M  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707304
• Other study ID #: LF-0207
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2008
• Last updated: August 13, 2012
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00937209

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Talactoferrin
Oral, 1.5 grams twice per day
• Placebo
Oral, twice per day

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Countries where clinical trial is conducted

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, 

Outcome

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