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

Information source: Agennix
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Talactoferrin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Agennix

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.

Clinical Details

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

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

Primary outcome: Overall survival

Secondary outcome:

Progression free survival

Objective response and disease stablization rate

Safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

UMHAT 'Dr. Georgi Stranski', EAD, Pleven 5800, Bulgaria

DDODIU-Plovdiv, EOOD, Plovdiv 4004, Bulgaria

DDODIU - Sofia District EOOD, Sofia 1233, Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia 1527, Bulgaria

Institut Onkologie a Rehabilitace Na Plesi, Nova Ves pod Plesi 262 04, Czech Republic

Fakultni Nemocnice Ostrava, Ostrava 708 52, Czech Republic

Vitkovicka nemocnice a.s., Ostrava 700 30, Czech Republic

Pardubicka krajska nemocnice, a.s., Pardubice 532 03, Czech Republic

Fakultni Nemocnice Kralovske Vinohrady, Praha 100 00, Czech Republic

Fakultni nemocnice v Motole, s.p., Praha 150 06, Czech Republic

Oblastni nemocnice Pribram, a.s., Pribram 261 95, Czech Republic

Nemocnice Tabor, a.s., Tabor 390 03, Czech Republic

CHU Angers, Angers cedex 49933, France

Hopital Morvan, Brest 29200, France

Centre Francois Baclesse, Caen Cedex 14076, France

Centre d'Oncology de Gentilly, Cedex 54100, France

Centre Hospitalier du Mans, Le Mans Cedex 72037, France

Centre Léon Berard, Lyon 69008, France

Hopital Sainte Marguerite, Marseille Cedex 9 13274, France

Hôpital Saint-Antoine, Paris 75012, France

Centre Hospitalier Lyon Sud, Pierre Bénite Cedex 69495, France

Hopital Maison Blanche, Reims 51100, France

CHU de Nancy, Hopital de Brabois, Vandoeuvre les Nancy 54500, France

Thoraxklinik-Heidelberg gGmbH, Heidelberg 69126, Germany

General Hospital of Athens "Sotiria", Athens 11527, Greece

University Hospital of Heraklio, Crete 71110, Greece

General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, Greece

Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest 1529, Hungary

Semmelweis Egyetem, Budapest 1125, Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc 3526, Hungary

Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz, Nyiregyháza 4412, Hungary

Torokbalinti Tudogyogyintezet, Torokbalint 2045, Hungary

Zala Megyei Korhaz, Zalaegerszeg 8900, Hungary

CRO Centro di Riferimento Oncologico di Aviano, Aviano 33081, Italy

Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona 26100, Italy

Dr. Anna Levcenko GP and Internist Practice, Daugavpils LV-5403, Latvia

Piejuras Hospital, Liepaja LV-4301, Latvia

P. Stradina Clinical University Hospital, Riga LV1002, Latvia

Riga Eastern Clinical University Hospital, Riga LV-1079, Latvia

Manila Doctors Hospital, Manila 1000, Philippines

Lung Center of the Philippines, Quezon City 1100, Philippines

St. Luke's Medical Center, Quezon City 1102, Philippines

Akademickie Centrum Kliniczne - Szpital AM w Gdansku, Gdansk 80-952, Poland

Nzoz Vesalius, Krakow 31-108, Poland

Miedziowe Centrum Zdrowia S.A., Lubin 59-301, Poland

NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o, Olsztyn 10-513, Poland

Specjalistyczny Szpital im. Prof. A. Sokolowskiego, Szczecin 70-891, Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warszawa 02-781, Poland

Spitalul Judetean de Urgenta "Dr. Constantin Opris", Baia Mare 430031, Romania

Spitalul Judetean de Urgenta Braila, Braila 810325, Romania

S.C. Ianuli Med Consult S.R.L., Bucuresti 020962, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Cluj-Napoca 400015, Romania

Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava, Suceava 720237, Romania

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk 163045, Russian Federation

SHI Altay Regional Oncology Dispensary, Barnaul 656052, Russian Federation

CCH #2 n.a. N. A. Semashko of LLC "Russian Railways", Moscow 129128, Russian Federation

City Clinical Hospital #1, Novosibirsk 630047, Russian Federation

Perm Territorial Oncology Dispensary, Perm 614066, Russian Federation

SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov", St. Petersburg 197022, Russian Federation

National Cancer Centre, Hospital Drive 169610, Singapore

Parkway Cancer Centre, Mount Elizabeth 258500, Singapore

Medical Oncology Centre, Napier Road 258500, Singapore

John Hopkins Singapore International Medical Centre, Singapore 308433, Singapore

H Mutua de Terrassa, Barcelona 08221, Spain

HU Virgen de las Nieves, Granada 18014, Spain

Fundacion Jimenez Diaz, Madrid 28040, Spain

HGU La Paz, Madrid 28046, Spain

Clinica Universitaria de Navarra, Pamplona 31008, Spain

Changhua Christian Hospital, Changhua 500, Taiwan

Kaohsiung Veterans General Hospital, Kaohsiung, 813, Taiwan

Taichung Veterans General Hospital, Taichung 403, Taiwan

National Cheng Kung University Hospital, Tainan 70428, Taiwan

Taipei Veterans General Hospital, Taipei 112, Taiwan

Chang-Gung Memorial Hospital, Linkou Branch, Toayuan 333, Taiwan

Gazi University Medical Faculty, Ankara 06500, Turkey

Gaziantep University Medical Faculty, Gaziantep, Turkey

Istanbul Bilim University Medical Fac., Istanbul 34394, Turkey

Ege University Medical Faculty, Izmir 35100, Turkey

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, Ancona, AN 60020, Italy

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

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

Desert Oasis Cancer Center, Casa Grande, Arizona 85122, United States

Arizona Oncology Associates, Tucson, Arizona 85710, United States

Praxis fuer interdisziplinaere Onkologie, Freiburg, BW 79106, Germany

Universitaetsklinikum Mannheim, Mannheim, BW 68167, Germany

Universitaetsklinikum Erlangen - PS, Erlangen, BY 91054, Germany

Asklepios Fachkliniken Muenchen-Gauting, Gauting, BY 82131, Germany

Klinikum rechts der Isar der TU Muenchen, Muenchen, BY 81675, Germany

Bristol Haematology & Oncology Centre, Bristol, Brist BS2 8ED, United Kingdom

Istituto per la Ricerca e la Cura del Cancro, Candiolo, Candiolo/TO 10060, Italy

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

Chonnam National University Hwasun Hospital, Hwasun up, Chonnam 519-809, Korea, Republic of

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Str. Republicii nr. 34-36, Cluj-Napoca 400015, Romania

University of Colorado Hospital, Aurora, Colorado 80045, United States

General Hospital of Chania 'Ag. Georgios', Mournies, Crete 73300, Greece

Nilai Cancer Institute (NCI Cancer Hospital), Negeri Sembilan, Darul Khusus 71800, Malaysia

Pasco Pinellas Cancer Center, New Port Richey, Florida 34652, United States

Lam Wah Ee Hospital, Pulau Pinang, Georgetown, 11600, Malaysia

Emory University, Atlanta, Georgia 30322, United States

National Cancer Center, Ilsandong-gu, Goyang 411-769, Korea, Republic of

Guy's & St Thomas' NHS Foundation Trust, London, Gt Lon SE1 9RT, United Kingdom

Christie Hospital, Manchester, Gt Man M20 4BX, United Kingdom

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of

Gemeinschaftspraxis fuer Haematologie Onkologie, Wiesbaden, HE 65191, Germany

Southampton General Hospital, Southampton, Hants SO16 6YD, United Kingdom

Castle Hill Hospital, Cottingham Hull, Hull HU16 5JQ, United Kingdom

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

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

Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia

Ospedale Versilia, Lido di Camaiore, LU 55043, Italy

University Hospital of Larissa, Mezourlo, Larissa 411 10, Greece

Istituto Nazionale Tumori, Milano, MI 20133, Italy

Azienda Ospedaliera San Gerardo, Monza, MI 20052, Italy

Kaushalya Medical Foundation Trust Hospital, Mumbai, Maharashtra 400601, India

P.D. Hinduja Nat. Hospital & Med. Research Centre, Mumbai, Maharashtra 400016, India

Tata Memorial Hospital, Mumbai, Maharashtra 400 012, 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

University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital, Wythenshawe, Manchester M23 9LT, United Kingdom

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

Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi, Csabai kapu, Miskolc 3529, Hungary

Washington University School of Medicine, St. Louis, Missouri 63128, United States

Universitaetsklinikum Goettingen, Goettingen, NI 37075, Germany

St. Johannes Hospital - PS, Dortmund, NW 44137, Germany

Centre Catherine de Sienne, Eric Tabarly, Nantes 44202, France

Southeast Nebraska Cancer Center, Lincoln, Nebraska 68510, United States

NH Oncology-Hematology, PA, Hooksett, New Hampshire 03106, United States

Campbelltown Hospital, Campbelltown, New South Wales 2560, Australia

Port Macquarie Base Hospital, Port Macquarie, New South Wales 2444, Australia

Montefiore Medical Center, Bronx, New York 10467, United States

University of Rochester Medical Center, Rochester, New York 14642, 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

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada

Kaiser Group Health, Portland, Oregon 97227, United States

Hospital Tengku Ampuan Afzan, Kuantan, Pahang 25100, Malaysia

University General Hospital of Patras, Rion, Patras 26505, Greece

DDODIU-Plovdiv, EOOD, Aleksandur Stamboliyski, Plovdiv 4004, Bulgaria

Fakultni nemocnice Na Bulovce, Budinova, Praha 180 00, Czech Republic

Hôtel-Dieu de Lévis, Lévis, Quebec G6V 3Z1, Canada

Gerald Bronfman Centre for Clinical Research in Oncology, Montreal, Quebec H3A 1A1, Canada

Townsville Hospital, Townsville, Queensland 4814, Australia

Azienda Ospedaliera San Camillo Forlanini, Roma,, RM, Italy

Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan 302017, India

Searoc Cancer Hospital, Jaipur, Rajasthan 302013, India

Singleton Hospital, Swansea,, S Glam, SA2 8QA, United Kingdom

Krankenhaus Grosshansdorf, Woehrendamm, SH 22927, Germany

Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH, Halle, ST 06120, Germany

Samsung Medical Center, Gangnam-Gu, Seoul 135-710, Korea, Republic of

Seoul National University Hospital, Jongno-gu, Seoul 110-744, Korea, Republic of

Korea University Anam Hospital, Seongbuk-gu, Seoul 136-705, Korea, Republic of

Asan Medical Center, Songpa-gu, Seoul 138-736, Korea, Republic of

Oncology Dispensary #2 of Krasnodar Region, Dagomysskaya str., Sochi 354057, Russian Federation

The Queen Elisabeth Hospital, Woodville South, South Australia 5011, Australia

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

The Catholic University of Korea St. Vincent's Hospital, Paldal-gu, Suwon Gyeonggi-do 442-723, Korea, Republic of

Fejer Megyei Szent Gyorgy Korhaz, Seregelyesi, Szekesfehervar 8000, Hungary

Zentralklinik Bad Berka, Bad Berka, TH 99437, Germany

Dr. Kamakshi Memorial Hospital Pvt Ltd, Chennai, Tamilnadu 600100, India

Christian Medical College Hospital, Vellore, Tamilnadu 632002, India

Ninewells Hospital, Dundee, Tays DD1 9SY, United Kingdom

Texas Oncology, Dallas, Texas 75230, United States

Texas Oncology, Fort Worth, Texas 76104, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Ospedale Mater Salutis, Legnago, VR 37045, Italy

Epworth Healthcare, Richmond, Victoria 3121, Australia

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Salem, Virginia 24153, United States

University Hospital of Coventry and Warwickshire, Coventry, Warwks CV2 2DX, United Kingdom

Cancer Care Northwest, Spokane, Washington 99202, United States

Additional Information

Starting date: November 2008
Last updated: August 13, 2012

Page last updated: August 20, 2015

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