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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Talactoferrin
Placebo
Sponsored by
Agennix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Desert Oasis Cancer Center
  • Arizona Oncology Associates
  • University of Colorado Hospital
  • Pasco Pinellas Cancer Center
  • Emory University
  • Rush University Medical Center
  • Cancer Care Specialists of Central Illinois
  • Cancer Care & Hematology Specialists of Chicagoland
  • Central Indiana Cancer Centers
  • Kansas City Cancer Center, LLC
  • NCI, CCR, The Waren Grant Magnuson Clinical Center
  • Newland Medical Associates
  • Minnesota Oncology and Hematology, PA
  • Washington University School of Medicine
  • Southeast Nebraska Cancer Center
  • NH Oncology-Hematology, PA
  • Montefiore Medical Center
  • University of Rochester Medical Center
  • Alamance Regional Medical Center
  • Duke University Medical Center
  • Rex Cancer Center
  • Legacy Pharma Research
  • Signal Point Clinical Research Center
  • Kaiser Group Health
  • Texas Oncology
  • Texas Oncology
  • Tyler Cancer Center
  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Cancer Care Northwest
  • Campbelltown Hospital
  • Port Macquarie Base Hospital
  • Townsville Hospital
  • The Queen Elisabeth Hospital
  • Epworth Healthcare
  • DDODIU-Plovdiv, EOOD
  • UMHAT 'Dr. Georgi Stranski', EAD
  • DDODIU-Plovdiv, EOOD
  • DDODIU - Sofia District EOOD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Cross Cancer Institute
  • Mount Sinai Hospital
  • Hôtel-Dieu de Lévis
  • Gerald Bronfman Centre for Clinical Research in Oncology
  • Fakultni nemocnice Na Bulovce
  • Institut Onkologie a Rehabilitace Na Plesi
  • Vitkovicka nemocnice a.s.
  • Fakultni Nemocnice Ostrava
  • Pardubicka krajska nemocnice, a.s.
  • Fakultni Nemocnice Kralovske Vinohrady
  • Fakultni nemocnice v Motole, s.p.
  • Oblastni nemocnice Pribram, a.s.
  • Nemocnice Tabor, a.s.
  • Hopital Cardiologique, Chru Lille
  • CHU Pontchaillou
  • CRLCC René Gauducheau
  • CLCC Paul Strauss
  • Hopital Larrey
  • Centre Catherine de Sienne
  • CHU Angers
  • Hopital Morvan
  • Centre Francois Baclesse
  • Centre d'Oncology de Gentilly
  • Centre Hospitalier du Mans
  • Centre Léon Berard
  • Hopital Sainte Marguerite
  • Hôpital Saint-Antoine
  • Centre Hospitalier Lyon Sud
  • Hopital Maison Blanche
  • CHU de Nancy, Hopital de Brabois
  • Praxis fuer interdisziplinaere Onkologie
  • Universitaetsklinikum Mannheim
  • Universitaetsklinikum Erlangen - PS
  • Asklepios Fachkliniken Muenchen-Gauting
  • Klinikum rechts der Isar der TU Muenchen
  • Gemeinschaftspraxis fuer Haematologie Onkologie
  • Universitaetsklinikum Goettingen
  • St. Johannes Hospital - PS
  • Krankenhaus Grosshansdorf
  • Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
  • Zentralklinik Bad Berka
  • Thoraxklinik-Heidelberg gGmbH
  • General Hospital of Chania 'Ag. Georgios'
  • University Hospital of Larissa
  • University General Hospital of Patras
  • General Hospital of Athens "Sotiria"
  • University Hospital of Heraklio
  • General Hospital of Thessaloniki "G. Papanikolaou"
  • Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
  • Fejer Megyei Szent Gyorgy Korhaz
  • Semmelweis Egyetem
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
  • Torokbalinti Tudogyogyintezet
  • Zala Megyei Korhaz
  • King George Hospital
  • Apollo Hospital
  • Indo-American Cancer Institute and Research Center
  • Kidwai Institute of Oncology
  • M. S. Ramaiah Memorial Hospital
  • A.J. Medical College Hosptial
  • Tata Memorial Hospital
  • P.D. Hinduja Nat. Hospital & Med. Research Centre
  • Kaushalya Medical Foundation Trust Hospital
  • Cancer Care Clinic
  • Shatabdi Hospital
  • Deenanath Mangeshkar Hospital and Research Center
  • Searoc Cancer Hospital
  • Mahaveer Cancer Hospital and Research Centre
  • Dr. Kamakshi Memorial Hospital Pvt Ltd
  • Christian Medical College Hospital
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
  • Istituto per la Ricerca e la Cura del Cancro
  • Ospedale Versilia
  • Istituto Nazionale Tumori
  • Azienda Ospedaliera San Gerardo
  • Azienda Ospedaliera San Camillo Forlanini
  • Ospedale Mater Salutis
  • CRO Centro di Riferimento Oncologico di Aviano
  • Azienda Ospedaliera Istituti Ospitalieri di Cremona
  • Chonnam National University Hwasun Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Korea University Anam Hospital
  • Asan Medical Center
  • The Catholic University of Korea St. Vincent's Hospital
  • Dr. Anna Levcenko GP and Internist Practice
  • Piejuras Hospital
  • Riga Eastern Clinical University Hospital
  • P. Stradina Clinical University Hospital
  • Nilai Cancer Institute (NCI Cancer Hospital)
  • Lam Wah Ee Hospital
  • Hospital Universiti Sains Malaysia
  • Hospital Tengku Ampuan Afzan
  • Manila Doctors Hospital
  • Lung Center of the Philippines
  • St. Luke's Medical Center
  • Akademickie Centrum Kliniczne - Szpital AM w Gdansku
  • Nzoz Vesalius
  • Miedziowe Centrum Zdrowia S.A.
  • NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
  • Specjalistyczny Szpital im. Prof. A. Sokolowskiego
  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris"
  • Spitalul Judetean de Urgenta Braila
  • S.C. Ianuli Med Consult S.R.L.
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
  • Oncology Dispensary #2 of Krasnodar Region
  • Arkhangelsk Regional Clinical Oncology Dispensary
  • SHI Altay Regional Oncology Dispensary
  • CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
  • City Clinical Hospital #1
  • Perm Territorial Oncology Dispensary
  • SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
  • National Cancer Centre
  • Parkway Cancer Centre
  • Medical Oncology Centre
  • John Hopkins Singapore International Medical Centre
  • H Mutua de Terrassa
  • HU Virgen de las Nieves
  • Fundacion Jimenez Diaz
  • HGU La Paz
  • Clinica Universitaria de Navarra
  • Changhua Christian Hospital
  • Kaohsiung Veterans General Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Chang-Gung Memorial Hospital, Linkou Branch
  • Gazi University Medical Faculty
  • Gaziantep University Medical Faculty
  • Istanbul Bilim University Medical Fac.
  • Ege University Medical Faculty
  • Bristol Haematology & Oncology Centre
  • Guy's & St Thomas' NHS Foundation Trust
  • Christie Hospital
  • Southampton General Hospital
  • Castle Hill Hospital
  • University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
  • Singleton Hospital
  • University Hospital of North Staffordshire
  • Wolverhampton New Cross Hospital
  • Beatson West of Scotland Cancer Centre
  • Ninewells Hospital
  • University Hospital of Coventry and Warwickshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression free survival
Objective response and disease stablization rate
Safety and tolerability

Full Information

First Posted
June 26, 2008
Last Updated
August 13, 2012
Sponsor
Agennix
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1. Study Identification

Unique Protocol Identification Number
NCT00707304
Brief Title
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Talactoferrin
Other Intervention Name(s)
talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF
Intervention Description
Oral, 1.5 grams twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, twice per day
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
After the occurence of the required number of events
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
At time of final analysis
Title
Objective response and disease stablization rate
Time Frame
At time of final analysis
Title
Safety and tolerability
Time Frame
At time of final analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Desert Oasis Cancer Center
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85122
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Pasco Pinellas Cancer Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Cancer Care & Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Kansas City Cancer Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
NCI, CCR, The Waren Grant Magnuson Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Newland Medical Associates
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Minnesota Oncology and Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55405
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
NH Oncology-Hematology, PA
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Rex Cancer Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Legacy Pharma Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Kaiser Group Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
The Queen Elisabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Epworth Healthcare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
DDODIU-Plovdiv, EOOD
City
Aleksandur Stamboliyski
State/Province
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
DDODIU-Plovdiv, EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
DDODIU - Sofia District EOOD
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Gerald Bronfman Centre for Clinical Research in Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Fakultni nemocnice Na Bulovce
City
Budinova
State/Province
Praha
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
Institut Onkologie a Rehabilitace Na Plesi
City
Nova Ves pod Plesi
ZIP/Postal Code
262 04
Country
Czech Republic
Facility Name
Vitkovicka nemocnice a.s.
City
Ostrava
ZIP/Postal Code
700 30
Country
Czech Republic
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Pardubicka krajska nemocnice, a.s.
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole, s.p.
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Oblastni nemocnice Pribram, a.s.
City
Pribram
ZIP/Postal Code
261 95
Country
Czech Republic
Facility Name
Nemocnice Tabor, a.s.
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Hopital Cardiologique, Chru Lille
City
Lille
State/Province
Cedex
ZIP/Postal Code
590
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
CRLCC René Gauducheau
City
Saint-herblain
State/Province
Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
CLCC Paul Strauss
City
Strasbourg
State/Province
Cedex
ZIP/Postal Code
67085
Country
France
Facility Name
Hopital Larrey
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Catherine de Sienne
City
Eric Tabarly
State/Province
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
CHU Angers
City
Angers cedex
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Francois Baclesse
City
Caen Cedex
ZIP/Postal Code
14076
Country
France
Facility Name
Centre d'Oncology de Gentilly
City
Cedex
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans Cedex
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Léon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Sainte Marguerite
City
Marseille Cedex 9
ZIP/Postal Code
13274
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Nancy, Hopital de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Praxis fuer interdisziplinaere Onkologie
City
Freiburg
State/Province
BW
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Mannheim
City
Mannheim
State/Province
BW
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Erlangen - PS
City
Erlangen
State/Province
BY
ZIP/Postal Code
91054
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen-Gauting
City
Gauting
State/Province
BY
ZIP/Postal Code
82131
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen
City
Muenchen
State/Province
BY
ZIP/Postal Code
81675
Country
Germany
Facility Name
Gemeinschaftspraxis fuer Haematologie Onkologie
City
Wiesbaden
State/Province
HE
ZIP/Postal Code
65191
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
State/Province
NI
ZIP/Postal Code
37075
Country
Germany
Facility Name
St. Johannes Hospital - PS
City
Dortmund
State/Province
NW
ZIP/Postal Code
44137
Country
Germany
Facility Name
Krankenhaus Grosshansdorf
City
Woehrendamm
State/Province
SH
ZIP/Postal Code
22927
Country
Germany
Facility Name
Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
City
Halle
State/Province
ST
ZIP/Postal Code
06120
Country
Germany
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
State/Province
TH
ZIP/Postal Code
99437
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
General Hospital of Chania 'Ag. Georgios'
City
Mournies
State/Province
Crete
ZIP/Postal Code
73300
Country
Greece
Facility Name
University Hospital of Larissa
City
Mezourlo
State/Province
Larissa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
University General Hospital of Patras
City
Rion
State/Province
Patras
ZIP/Postal Code
26505
Country
Greece
Facility Name
General Hospital of Athens "Sotiria"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital of Heraklio
City
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou"
City
Thessaloniki
Country
Greece
Facility Name
Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
City
Csabai kapu
State/Province
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz
City
Seregelyesi
State/Province
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
City
Nyiregyháza
ZIP/Postal Code
4412
Country
Hungary
Facility Name
Torokbalinti Tudogyogyintezet
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Zala Megyei Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
King George Hospital
City
Vishakhapattanam
State/Province
Andhhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Apollo Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500033
Country
India
Facility Name
Indo-American Cancer Institute and Research Center
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Kidwai Institute of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
Facility Name
M. S. Ramaiah Memorial Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
A.J. Medical College Hosptial
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
P.D. Hinduja Nat. Hospital & Med. Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Kaushalya Medical Foundation Trust Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400601
Country
India
Facility Name
Cancer Care Clinic
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Shatabdi Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Searoc Cancer Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302013
Country
India
Facility Name
Mahaveer Cancer Hospital and Research Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Dr. Kamakshi Memorial Hospital Pvt Ltd
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600100
Country
India
Facility Name
Christian Medical College Hospital
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632002
Country
India
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
City
Ancona
State/Province
AN
ZIP/Postal Code
60020
Country
Italy
Facility Name
Istituto per la Ricerca e la Cura del Cancro
City
Candiolo
State/Province
Candiolo/TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Versilia
City
Lido di Camaiore
State/Province
LU
ZIP/Postal Code
55043
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
State/Province
MI
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma,
State/Province
RM
Country
Italy
Facility Name
Ospedale Mater Salutis
City
Legnago
State/Province
VR
ZIP/Postal Code
37045
Country
Italy
Facility Name
CRO Centro di Riferimento Oncologico di Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun up
State/Province
Chonnam
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Ilsandong-gu
State/Province
Goyang
ZIP/Postal Code
411-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do,
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Gangnam-Gu
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seongbuk-gu
State/Province
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Paldal-gu
State/Province
Suwon Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Dr. Anna Levcenko GP and Internist Practice
City
Daugavpils
ZIP/Postal Code
LV-5403
Country
Latvia
Facility Name
Piejuras Hospital
City
Liepaja
ZIP/Postal Code
LV-4301
Country
Latvia
Facility Name
Riga Eastern Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
P. Stradina Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Nilai Cancer Institute (NCI Cancer Hospital)
City
Negeri Sembilan
State/Province
Darul Khusus
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Lam Wah Ee Hospital
City
Pulau Pinang
State/Province
Georgetown,
ZIP/Postal Code
11600
Country
Malaysia
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Lung Center of the Philippines
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Akademickie Centrum Kliniczne - Szpital AM w Gdansku
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Nzoz Vesalius
City
Krakow
ZIP/Postal Code
31-108
Country
Poland
Facility Name
Miedziowe Centrum Zdrowia S.A.
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Specjalistyczny Szpital im. Prof. A. Sokolowskiego
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Str. Republicii nr. 34-36
State/Province
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Braila
City
Braila
ZIP/Postal Code
810325
Country
Romania
Facility Name
S.C. Ianuli Med Consult S.R.L.
City
Bucuresti
ZIP/Postal Code
020962
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Oncology Dispensary #2 of Krasnodar Region
City
Dagomysskaya str.
State/Province
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Oncology Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
SHI Altay Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656052
Country
Russian Federation
Facility Name
CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
City Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Perm Territorial Oncology Dispensary
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
National Cancer Centre
City
Hospital Drive
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Parkway Cancer Centre
City
Mount Elizabeth
ZIP/Postal Code
258500
Country
Singapore
Facility Name
Medical Oncology Centre
City
Napier Road
ZIP/Postal Code
258500
Country
Singapore
Facility Name
John Hopkins Singapore International Medical Centre
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
H Mutua de Terrassa
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
HU Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
HGU La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung,
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70428
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou Branch
City
Toayuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Gaziantep University Medical Faculty
City
Gaziantep
Country
Turkey
Facility Name
Istanbul Bilim University Medical Fac.
City
Istanbul
ZIP/Postal Code
34394
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
State/Province
Brist
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
State/Province
Gt Lon
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
Gt Man
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hants
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham Hull
State/Province
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea,
State/Province
S Glam,
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke on Trent
State/Province
Staffs
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Wolverhampton New Cross Hospital
City
Wolverhampton
State/Province
Staffs
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Strath
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Tays
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University Hospital of Coventry and Warwickshire
City
Coventry
State/Province
Warwks
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

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

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