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Non Small Cell Lung CancerPhase 3FORTIS-MNCT00707304

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

A Phase 3 study testing Talactoferrin in people with Non Small Cell Lung Cancer, run by Agennix at 189 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Talactoferrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
742 participants
Where
189 sitesin 23 countries
Study dates
Nov 2008to Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

189 sites in 23 countries.

189 sites in 23 countries

United States29 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • NCI, CCR, The Waren Grant Magnuson Clinical Center

    Bethesda, Maryland, 20892

  • Legacy Pharma Research

    Bismarck, North Dakota, 58501

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85122

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Texas Oncology

    Dallas, Texas, 75230

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Oncology

    Fort Worth, Texas, 76104

  • Central Indiana Cancer Centers

    Greenfield, Indiana, 46140

  • NH Oncology-Hematology, PA

    Hooksett, New Hampshire, 03106

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Minnesota Oncology and Hematology, PA

    Minneapolis, Minnesota, 55405

  • Pasco Pinellas Cancer Center

    New Port Richey, Florida, 34652

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Kansas City Cancer Center, LLC

    Overland Park, Kansas, 66210

  • Kaiser Group Health

    Portland, Oregon, 97227

  • Rex Cancer Center

    Raleigh, North Carolina, 27609

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Newland Medical Associates

    Southfield, Michigan, 48075

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • Washington University School of Medicine

    St Louis, Missouri, 63128

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Arizona Oncology Associates

    Tucson, Arizona, 85710

  • Tyler Cancer Center

    Tyler, Texas, 75702

Other trials in United States

France17 sites

  • CHU Angers

    Angers, Angers Cedex, 49933

  • Hopital Morvan

    Brest, 29200

  • Centre Francois Baclesse

    Caen, Caen Cedex, 14076

  • Centre d'Oncology de Gentilly

    Cedex, Cedex, 54100

  • Centre Catherine de Sienne

    Eric Tabarly, Nantes, 44202

  • Centre Hospitalier du Mans

    Le Mans, Le Mans Cedex, 72037

  • Hopital Cardiologique, Chru Lille

    Lille, Cedex, 590

  • Centre Léon Berard

    Lyon, Lyon, 69008

  • Hopital Sainte Marguerite

    Marseille, 13274

  • Hôpital Saint-Antoine

    Paris, Paris, 75012

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Maison Blanche

    Reims, Reims, 51100

  • CHU Pontchaillou

    Rennes, Cedex, 35033

  • CRLCC René Gauducheau

    Saint-Herblain, Cedex, 44805

  • CLCC Paul Strauss

    Strasbourg, Cedex, 67085

  • Hopital Larrey

    Toulouse, Cedex, 31059

  • CHU de Nancy, Hopital de Brabois

    Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500

Other trials in France

India16 sites

  • Kidwai Institute of Oncology

    Bangalore, Karnataka, 560029

  • M. S. Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • Dr. Kamakshi Memorial Hospital Pvt Ltd

    Chennai, Tamil Nadu, 600100

  • Apollo Hospital

    Hyderabad, Andhra Pradesh, 500033

  • Indo-American Cancer Institute and Research Center

    Hyderabad, Andhra Pradesh, 500034

  • Searoc Cancer Hospital

    Jaipur, Rajasthan, 302013

  • Mahaveer Cancer Hospital and Research Centre

    Jaipur, Rajasthan, 302017

  • A.J. Medical College Hosptial

    Mangalore, Karnataka, 575001

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400 012

  • P.D. Hinduja Nat. Hospital & Med. Research Centre

    Mumbai, Maharashtra, 400016

  • Kaushalya Medical Foundation Trust Hospital

    Mumbai, Maharashtra, 400601

  • Cancer Care Clinic

    Nagpur, Maharashtra, 440012

  • Shatabdi Hospital

    Nashik, Maharashtra, 422005

  • Deenanath Mangeshkar Hospital and Research Center

    Pune, Maharashtra, 411 004

  • Christian Medical College Hospital

    Vellore, Tamil Nadu, 632002

  • King George Hospital

    Vishakhapattanam, Andhhra Pradesh, 530002

Other trials in India

Germany12 sites

  • Zentralklinik Bad Berka

    Bad Berka, Thuringia, 99437

  • St. Johannes Hospital - PS

    Dortmund, North Rhine-Westphalia, 44137

  • Universitaetsklinikum Erlangen - PS

    Erlangen, Bavaria, 91054

  • Praxis fuer interdisziplinaere Onkologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Asklepios Fachkliniken Muenchen-Gauting

    Gauting, Bavaria, 82131

  • Universitaetsklinikum Goettingen

    Göttingen, Lower Saxony, 37075

  • Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, Saxony-Anhalt, 06120

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Heidelberg, 69126

  • Universitaetsklinikum Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Gemeinschaftspraxis fuer Haematologie Onkologie

    Wiesbaden, Hesse, 65191

  • Krankenhaus Grosshansdorf

    Woehrendamm, Schleswig-Holstein, 22927

Other trials in Germany

United Kingdom12 sites

  • Bristol Haematology & Oncology Centre

    Bristol, Brist, BS2 8ED

  • Castle Hill Hospital

    Cottingham Hull, Hull, HU16 5JQ

  • University Hospital of Coventry and Warwickshire

    Coventry, Warwks, CV2 2DX

  • Ninewells Hospital

    Dundee, Tays, DD1 9SY

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strath, G12 0YN

  • Guy's & St Thomas' NHS Foundation Trust

    London, Gt Lon, SE1 9RT

  • Christie Hospital

    Manchester, Gt Man, M20 4BX

  • Southampton General Hospital

    Southampton, Hants, SO16 6YD

  • University Hospital of North Staffordshire

    Stoke-on-Trent, Staffs, ST4 7LN

  • Singleton Hospital

    Swansea, S Glam,, SA2 8QA

  • Wolverhampton New Cross Hospital

    Wolverhampton, Staffs, WV10 0QP

  • University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital

    Wythenshawe, Manchester, M23 9LT

Other trials in United Kingdom

Czechia9 sites

  • Fakultni nemocnice Na Bulovce

    Budinova, Prague, 180 00

  • Institut Onkologie a Rehabilitace Na Plesi

    Nová Ves pod Pleší, 262 04

  • Vitkovicka nemocnice a.s.

    Ostrava, 700 30

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

  • Pardubicka krajska nemocnice, a.s.

    Pardubice, Pardubice, 532 03

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 100 00

  • Fakultni nemocnice v Motole, s.p.

    Prague, 150 06

  • Oblastni nemocnice Pribram, a.s.

    Příbram, Pribram, 261 95

  • Nemocnice Tabor, a.s.

    Tábor, 390 03

Other trials in Czechia

Italy9 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

    Ancona, AN, 60020

  • CRO Centro di Riferimento Oncologico di Aviano

    Aviano, Aviano, 33081

  • Istituto per la Ricerca e la Cura del Cancro

    Candiolo, Candiolo/TO, 10060

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, Cremona, 26100

  • Ospedale Mater Salutis

    Legnago, VR, 37045

  • Ospedale Versilia

    Lido di Camaiore, LU, 55043

  • Istituto Nazionale Tumori

    Milan, MI, 20133

  • Azienda Ospedaliera San Gerardo

    Monza, MI, 20052

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, RM

Other trials in Italy

Hungary8 sites

  • Semmelweis Egyetem

    Budapest, Budapest, 1125

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, Budapest, 1529

  • Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi

    Csabai Kapu, Miskolc, 3529

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, Miskolc, 3526

  • Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz

    Nyiregyháza, Nyiregyháza, 4412

  • Fejer Megyei Szent Gyorgy Korhaz

    Seregelyesi, Szekesfehervar, 8000

  • Torokbalinti Tudogyogyintezet

    Törökbálint, Torokbalint, 2045

  • Zala Megyei Korhaz

    Zalaegerszeg, Zalaegerszeg, 8900

Other trials in Hungary

South Korea8 sites

  • Samsung Medical Center

    Gangnam-Gu, Seoul, 135-710

  • Chonnam National University Hwasun Hospital

    Hwasun Up, Chonnam, 519-809

  • National Cancer Center

    Ilsandong-gu, Goyang, 411-769

  • Seoul National University Hospital

    Jongno-gu, Seoul, 110-744

  • The Catholic University of Korea St. Vincent's Hospital

    Paldal-gu, Suwon Gyeonggi-do, 442-723

  • Korea University Anam Hospital

    Seongbuk-gu, Seoul, 136-705

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Asan Medical Center

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

Russia7 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • SHI Altay Regional Oncology Dispensary

    Barnaul, Barnaul, 656052

  • Oncology Dispensary #2 of Krasnodar Region

    Dagomysskaya Str., Sochi, 354057

  • CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"

    Moscow, Moscow, 129128

  • City Clinical Hospital #1

    Novosibirsk, Novosibirsk Oblast, 630047

  • Perm Territorial Oncology Dispensary

    Perm, Perm Krai, 614066

  • SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"

    Saint Petersburg, Sankt-Peterburg, 197022

Other trials in Russia

Greece6 sites

  • General Hospital of Athens "Sotiria"

    Athens, Athens, 11527

  • University Hospital of Heraklio

    Crete, Crete, 71110

  • University Hospital of Larissa

    Mezourlo, Larissa, 411 10

  • General Hospital of Chania 'Ag. Georgios'

    Mourniés, Crete, 73300

  • University General Hospital of Patras

    Rio, Patras, 26505

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki

Other trials in Greece

Poland6 sites

  • Akademickie Centrum Kliniczne - Szpital AM w Gdansku

    Gdansk, Gdansk, 80-952

  • Nzoz Vesalius

    Krakow, Krakow, 31-108

  • Miedziowe Centrum Zdrowia S.A.

    Lubin, Lubin, 59-301

  • NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

    Olsztyn, Olsztyn, 10-513

  • Specjalistyczny Szpital im. Prof. A. Sokolowskiego

    Szczecin, Szczecin, 70-891

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, Warszawa, 02-781

Other trials in Poland

Romania6 sites

  • Spitalul Judetean de Urgenta "Dr. Constantin Opris"

    Baia Mare, 430031

  • Spitalul Judetean de Urgenta Braila

    Brăila, Brăila County, 810325

  • S.C. Ianuli Med Consult S.R.L.

    Bucharest, Bucharest, 020962

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

    Cluj-Napoca, 400015

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

    Str. Republicii Nr. 34-36, Cluj-Napoca, 400015

  • Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

    Suceava, Suceava, 720237

Other trials in Romania

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, Changhua, 500

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Kaohsiung, 813

  • Taichung Veterans General Hospital

    Taichung, Taichung, 403

  • National Cheng Kung University Hospital

    Tainan, Tainan, 70428

  • Taipei Veterans General Hospital

    Taipei, Taipei, 112

  • Chang-Gung Memorial Hospital, Linkou Branch

    Toayuan, Toayuan, 333

Other trials in Taiwan

Australia5 sites

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Epworth Healthcare

    Richmond, Victoria, 3121

  • Townsville Hospital

    Townsville, Queensland, 4814

  • The Queen Elisabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Bulgaria5 sites

  • DDODIU-Plovdiv, EOOD

    Aleksandur Stamboliyski, Plovdiv, 4004

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, Pleven, 5800

  • DDODIU-Plovdiv, EOOD

    Plovdiv, Plovdiv, 4004

  • DDODIU - Sofia District EOOD

    Sofia, 1233

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

Other trials in Bulgaria

Spain5 sites

  • H Mutua de Terrassa

    Barcelona, Barcelona, 08221

  • HU Virgen de las Nieves

    Granada, Granada, 18014

  • Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

  • HGU La Paz

    Madrid, Madrid, 28046

  • Clinica Universitaria de Navarra

    Pamplona, Pamplona, 31008

Other trials in Spain

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hôtel-Dieu de Lévis

    Lévis, Quebec, G6V 3Z1

  • Gerald Bronfman Centre for Clinical Research in Oncology

    Montreal, Quebec, H3A 1A1

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Latvia4 sites

  • Dr. Anna Levcenko GP and Internist Practice

    Daugavpils, LV-5403

  • Piejuras Hospital

    Liepāja, LV-4301

  • Riga Eastern Clinical University Hospital

    Riga, LV-1079

  • P. Stradina Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

Malaysia4 sites

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

  • Nilai Cancer Institute (NCI Cancer Hospital)

    Negeri Sembilan, Darul Khusus, 71800

  • Lam Wah Ee Hospital

    Pulau Pinang, Georgetown,, 11600

Other trials in Malaysia

Singapore4 sites

  • National Cancer Centre

    Hospital Drive, Singapore, 169610

  • Parkway Cancer Centre

    Mount Elizabeth, Singapore, 258500

  • Medical Oncology Centre

    Napier Road, Singapore, 258500

  • John Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Turkey (Türkiye)4 sites

  • Gazi University Medical Faculty

    Ankara, Ankara, 06500

  • Gaziantep University Medical Faculty

    Gaziantep, Gaziantep

  • Istanbul Bilim University Medical Fac.

    Istanbul, 34394

  • Ege University Medical Faculty

    Izmir, 35100

Other trials in Turkey (Türkiye)

Philippines3 sites

  • Manila Doctors Hospital

    Manila, 1000

  • St. Luke's Medical Center

    Quezon City, Quezon City, 1102

  • Lung Center of the Philippines

    Quezon City, 1100

Other trials in Philippines

About this study

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

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.

Being tested
Talactoferrin, Placebo
Keywords
Non Small Cell Lung Cancer, Talactoferrin, Dendritic Cell Recruiter and Activator, Immunomodulatory agent
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalactoferrinDrug

    Also called talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF

    Oral, 1.5 grams twice per day

  • PlaceboDrug

    Oral, twice per day

Study groups in NCT00707304
Study groupRoleWhat they receive
1ExperimentalTalactoferrin 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.
Receives: Drug: Talactoferrin
2Placebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: After the occurence of the required number of events

Secondary outcomes (3)

  1. Progression free survival

    Measured: At time of final analysis

  2. Objective response and disease stablization rate

    Measured: At time of final analysis

  3. Safety and tolerability

    Measured: At time of final analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMar 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00707304
Sponsor's protocol ID
LF-0207
Acronym
FORTIS-M
Status last verified
Aug 2012
First submitted
26 Jun 2008
Last updated
21 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Talactoferrin in people with Non Small Cell Lung Cancer, run by Agennix at 189 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, France, India, Germany, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: After the occurence of the required number of events). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00707304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.

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