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AzTrials

Renal Cell CarcinomaPhase 3INTORACTNCT00631371

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

A Phase 3 study testing Bevacizumab, Temsirolimus and Interferon-Alfa 9MU in people with Renal Cell Carcinoma, run by Pfizer at 172 sites in 30 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

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Bevacizumab, Temsirolimus and Interferon-Alfa 9MU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
791 participants
Where
172 sitesin 30 countries
Study dates
Apr 2008to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
  • Majority component of conventional clear-cell type is mandatory
  • At least 1 measurable lesion (per RECIST)

Who cannot join

  • Prior systemic treatment for RCC
  • Evidence of current or prior central nervous system (CNS) metastases
  • Cardiovascular disease
  • Pregnant or nursing women
  • Additional criteria applies

Trial locations and contacts

172 sites in 30 countries.

172 sites in 30 countries

United States25 sites

  • South County Hematology/Oncology

    Chula Vista, California, 91911

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Edmond Oncology Center

    Edmond, Oklahoma, 73034

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Hematology Oncology Services of Arkansas

    Little Rock, Arkansas, 72205

  • UCLA Medical Center

    Los Angeles, California, 90095-1694

  • UCLA

    Los Angeles, California, 90095-6984

  • UCLA

    Los Angeles, California, 90095

  • The Vanderbilt Clinic

    Nashville, Tennessee, 37232

  • The Jones Clinic, PC

    New Albany, Mississippi, 38652

  • North County Oncology Medical Clinic

    Oceanside, California, 92056

  • OU Medical Center

    Oklahoma City, Oklahoma, 73104

  • OU Physician's Building

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Medical Oncology Associates - SD

    San Diego, California, 92123

  • Sharp Memorial Hospital Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Pacific Hematology/Oncology Associates

    San Francisco, California, 94115

  • San Francisco Oncology Associates

    San Francisco, California, 94115

  • Cohen & Hufford MD's INC

    San Francisco, California, 94118

  • University of Washington Medical Center

    Seattle, Washington, 96195

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

Other trials in United States

Brazil13 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Centro Goiano de Oncologia

    Goiânia, Goiás, 74075-040

  • Centro Goiano de Oncologia - CGO

    Goiânia, Goiás, 74130-015

  • ProCura - Centro Goiano de Pesquisa Clínica Ltda

    Goiânia, Goiás, 74140-050

  • Associaçao Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Instituto de Oncologia de Piracicaba S/S Ltda

    Piracicaba, São Paulo, 13419-155

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Instituto Nacional do Cancer - INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Russia11 sites

  • Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic

    Kazan', 420029

  • Chair of Radiology and Radiotherapy

    Moscow, 105077

  • N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

    Moscow, 115478

  • N.N. Blokhin Russian Cancer Research Center, Department of Urology

    Moscow, 115478

  • Moscow Scientific Research Oncology Institute P.A. Herzen

    Moscow, 125284

  • Privolzhskiy District Medical Center of Federal Biomedical Agency

    Nizhny Novgorod, 603109

  • Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

    Obninsk, Kaluga Oblast, 249036

  • Scientific research Institute of Oncology N.N. Petrov

    Pesochny, Saint-Petersburg, 197758

  • City Hospital No.26

    Saint Petersburg, 196247

  • City Pokrovskaya Hospital

    Saint Petersburg, 199106

  • Leningrad Regional Oncology Dispensary

    Saint-Petersburg, Leningradskaya Oblast', 188663

Other trials in Russia

Slovakia11 sites

  • Fakultna Nemocnica s poliklinikou F D Roosevelta

    Banská Bystrica, 974 01

  • Oddelenie funkcnej diagnostiky

    Banská Bystrica, 974 01

  • Klinika pneumologie a ftiziologie FNsP LFUK

    Bratislava, 826 06

  • Fakultna Nemocnica s poliklinikou akad L Derera

    Bratislava, 833 05

  • Klinica nuklcarncj mediciny

    Martin, 036 59

  • Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice

    Martin, 036 59

  • Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince

    Martin, 036 59

  • Nemocnica s poliklinikou Skalica

    Skalica, 909 82

  • KK MED, s.r.o.

    Žilina, 012 07

  • MEDIVASA s.r.o.

    Žilina, 012 07

  • Nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

India10 sites

  • Vedanta Institute of Medical Sciences

    Ahmedabad, Gujarat, 380009

  • Healthcare Global Enterprises Limited

    Bangalore, Karnataka, 560027

  • Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology

    Bhopal, Madhya Pradesh, 462001

  • Apollo Hospital

    Chennai, Tamil Nadu, 600035

  • Searoc Cancer Centre

    Jaipur, Rajasthan, 302013

  • Regional Cancer Centre

    Kerela, Trivandrum, 695011

  • Lakeshore Hospital & Research Center Limited

    Kochi, Kerala, 682304

  • Tata Memorial Center

    Mumbai, Maharashtra, 400012

  • Tata Memorial Centre

    Navi Mumbai, Maharashtra, 410210

  • Jehangir Hospital

    Pune, Maharashtra, 411001

Other trials in India

France9 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Clinique Sainte Marguerite

    Hyères, 83400

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre médical Oncogard

    Nîmes, 30907

  • CHU de Poitiers

    Poitiers, 86021

  • CHU de Rouen

    Rouen, 76031

  • Centre rené Gauducheau

    Saint-Herblain-Nantes, 44805

  • Hopital Foch

    Suresnes, 92151

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Poland9 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80952

  • Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.

    Krakow, 31-826

  • Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli

    Lublin, 20-090

  • Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

    Poznan, 60-569

  • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie

    Warsaw, 02-781

  • Centrum Medyczne Ostrobramska NZOZ "Magodent"

    Warsaw, 04-125

  • Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr

    Warsaw, 04-141

  • Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON

    Warsaw, 04-141

  • Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON

    Warsaw, 04-141

Other trials in Poland

Ukraine9 sites

  • Universitet, kafedra onkologyy

    Chenivtsi, 58013

  • A.P Romodanov Itstitut nejrohirurhii

    Chernivtsi, 58001

  • Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo

    Donetsk, 83003

  • Donetskyy Oblasyy protypukhlynnyy Tsenter

    Donetsk, 83092

  • Donetske Obl. clinico-teritorial'ne medichne ob'yednannya

    Donetsk, 83099

  • "State Institution ""Institute for Occupational Health of the

    Kiev, 01033

  • R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator

    Kiev, 03115

  • A.P Romodanov Itstitut nejrohirurhii

    Kiyv, 04050

  • Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni

    Medychna Vul., Ivano-Frankivsk, 76018

Other trials in Ukraine

Italy7 sites

  • Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari

    Bari, 70124

  • Sezione di Oncologia Medica Centro di Ricerca Clinica

    Chieti, 66013

  • Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena

    Modena, 41100

  • Farmacia del Comitato Etico Provinciale di Modena

    Modena, 41124

  • Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia

    Perugia, 06132

  • IFO- Istituti Fisioterapici Ospitalieri

    Roma, 00144

  • Azienda Ospedaliera S. Maria

    Terni, 05100

Other trials in Italy

South Africa7 sites

  • Pretoria Urology Hospital

    Hatfield, Pretoria, 0083

  • GVI Oncology Trial Unit

    Kraaifontein, Cape Town, 7570

  • Westridge Medical Centre

    Mayville, Durban, 4001

  • Panorama Medical Centre

    Panorama, Cape Town, Western Cape, 7500

  • University of the Witwatersrand Oncology

    Parktown, 2193

  • Langenhoven Drive Oncology Centre

    Port Elizabeth, 6006

  • Dr. Fourie & Voges

    Pretoria, 0084

Other trials in South Africa

Hungary6 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Josa Andras Oktato Korhaz Nonprofit Kft.

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem, Urologiai Klinika

    Szeged, 6725

  • Veszprem Megyei Csolnoky Ferenc

    Veszprém, 8200

Other trials in Hungary

Spain6 sites

  • Hospital Sant Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital del mar de Barcelona

    Barcelona, 8003

  • Institut Catala Doncologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital de Madrid Norte-Sanchinarro

    Madrid, Madrid, 28050

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Cancer Care SA

    Kurralta Park, 5037

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Mater Private Hospital

    South Brisbane, QLD 4101

Other trials in Australia

Taiwan5 sites

  • Tri-Service General Hospital

    Neihu District, Tapei, 114

  • China Medical University Hospital

    Taichung, 404

  • Veterans General Hospital-Taipei

    Taipei, ROC, 11217

  • National Taiwan University Hospital

    Taipei TOC, Taiwan, 100

  • Division of Oncology

    Taoyuan, 333

Other trials in Taiwan

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Jessa Ziekenhuis - campus Virga Jessa

    Hasselt, 3500

  • Cliniques Universitaires de Mont-Godinne UCL

    Mont-Godinne, 5530

Other trials in Belgium

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Oblastni nemocnice Jicin a s

    Jičín, Ceska Republika, 506 43

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Krajska zdravotni, a.s.

    Ústí nad Labem, 401 13

Other trials in Czechia

Germany4 sites

  • Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH

    Berlin, 10967

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Klinikum Region Hannover, Krankenhaus Siloah

    Hanover, 30449

  • TU Muenchen, rechts der Isar

    München, 81675

Other trials in Germany

United Kingdom4 sites

  • University of Leeds

    Leeds, North Yorkshire, LS9 7TF

  • Guy's Hospital

    London, SE1 7EH

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Christie Hospital

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Argentina3 sites

  • Centro Oncológico Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000IAK

  • ISIS Clinica Especializado

    Santa Fe, Santa Fe Province, 3000

Other trials in Argentina

Chile3 sites

  • Instituto Clinico Oncologico del Sur

    Santiago, Chile

  • Instituto Nacional del Cancer

    Santiago, Region Metropolitana / Chile, 8380455

  • Fundacion Arturo Lopez Perez

    Santiago

Other trials in Chile

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

Other trials in Serbia

Canada2 sites

  • Centre de Sante et de Services Sociaux de Rimouski - Neigette

    Rimouski, Quebec, G5L 5T1

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Portugal2 sites

  • Hospital de San Joao

    Porto, 4200-319

  • Hospital de São João

    Porto, 4200-319

Other trials in Portugal

South Korea2 sites

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Yonsei University Health System-Severance Hospital

    Seoul, 120-752

Other trials in South Korea

Colombia1 site

  • Oncologos del Occidente S.A

    Pereira, Risaralda Department

Other trials in Colombia

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia, 59100

Other trials in Malaysia

Mexico1 site

  • Hospital Aranda de la Parra

    León, Guanajuato, 37000

Other trials in Mexico

Netherlands1 site

  • Spaarne Ziekenhuis

    Hoofddorp, 2134 TM

Other trials in Netherlands

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Being tested
Bevacizumab, Temsirolimus, Interferon-Alfa 9MU
Keywords
temsirolimus, renal cell carcinoma, kidney cancer, urogenital cancer
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Urogenital Neoplasms

What participants receive

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

  • BevacizumabDrug

    Also called Torisel

    Bevacizumab 10 mg/kg intravenous (IV) q8wks

  • TemsirolimusDrug

    Temsirolimus 25 mg IV weekly

  • BevacizumabDrug

    Bevacizumab 10 mg/kg intravenous (IV) q8wks

  • Interferon-Alfa 9MUDrug

    Interferon-Alfa 9MU SC TIW

Study groups in NCT00631371
Study groupRoleWhat they receive
1ExperimentalBevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Receives: Drug: Bevacizumab; Drug: Temsirolimus
2Active comparatorBevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Receives: Drug: Bevacizumab; Drug: Interferon-Alfa 9MU

What is being measured

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

  1. Progression-Free Survival (PFS): Independent-Assessment

    PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

    Measured: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Secondary outcomes (3)

  1. Progression-Free Survival (PFS): Investigator-Assessment

    PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

    Measured: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

  2. Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment

    Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

    Measured: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

  3. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

    Measured: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Timeline

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

  1. First posted7 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2012
  4. Study completionApr 2015

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
None (open label)
Enrolment
791 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00631371
Sponsor's protocol ID
3066K1-3311
Other IDs
B1771006, 2007-003793-26
Acronym
INTORACT
Status last verified
Mar 2016
First submitted
28 Feb 2008
Last updated
27 Apr 2016
Data monitoring committee
Yes

Publications

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

  • de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

    PubMed 28410911

  • Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

    PubMed 27238653

  • Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.

    PubMed 24297945

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Temsirolimus and Interferon-Alfa 9MU in people with Renal Cell Carcinoma, run by Pfizer at 172 sites in 30 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 3 inclusion and 5 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Brazil, Russia, Slovakia, India and 25 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. 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?

Yes. Results are posted in the registry (first posted 4 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS): Independent-Assessment (time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)). 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 NCT00631371, which also lists 4 linked publications.

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 27 Apr 2016.

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