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

August 13, 2012 updated by: Agennix

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

742

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Oral, 1.5 grams twice per day
Other Names:
  • talactoferrin alfa
  • TLF
  • recombinant human lactoferrin
  • rhLF
Placebo Comparator: 2
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.
Oral, twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: After the occurence of the required number of events
After the occurence of the required number of events

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: At time of final analysis
At time of final analysis
Objective response and disease stablization rate
Time Frame: At time of final analysis
At time of final analysis
Safety and tolerability
Time Frame: At time of final analysis
At time of final analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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