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Renal Cell CarcinomaPhase 3METEORNCT01865747

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

A Phase 3 study testing Cabozantinib tablets and Everolimus (Afinitor) tablets in people with Renal Cell Carcinoma, run by Exelixis at 205 sites in 26 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy. 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?
Cabozantinib tablets and Everolimus (Afinitor) tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
658 participants
Where
205 sitesin 26 countries
Study dates
Jun 2013to 15 Jan 2021
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

Select Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
  2. Measurable disease as determined by the investigator.
  3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
  4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  5. Adequate organ and marrow function.
  6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
  7. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

  1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
  2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
  3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
  4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
  7. Chronic treatment with corticosteroids or other immunosuppressive agents.
  8. Serious illness other than cancer.
  9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
  10. Pregnant or lactating females.
  11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.

Trial locations and contacts

205 sites in 26 countries.

205 sites in 26 countries

United States59 sites

  • Study site

    Albany, New York, 12206

  • Study site

    Anchorage, Alaska, 99503

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78731

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bedford, Texas, 76022

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80218

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Duarte, California, 91010

  • Study site

    Durham, North Carolina, 22710

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Gilbert, Arizona, 85234

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    La Jolla, California, 92093

  • Study site

    Las Vegas, Nevada, 89148

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Angeles, California, 90095

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33176

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New York, New York, 10065

  • Study site

    Orlando, Florida, 06520

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    Seattle, Washington, 98109

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Vallejo, California, 94589

  • Study site

    Vancouver, Washington, 98684

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Westwood, Kansas, 66205

  • Study site

    Yakima, Washington, 98902

Other trials in United States

Germany18 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, 12200

  • Study site

    Dresden, 01307

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Freiburg im Breisgau, Baden Wuttemberg, 79106

  • Study site

    Gütersloh, 33332

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, 30605

  • Study site

    Heidelberg, 69120

  • Study site

    Jena, Thuringia, 99089

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, 81675

  • Study site

    Munich, 81377

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Australia14 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Bentleight East, Victoria, 3165

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Milton, Queensland, 4064

  • Study site

    Port Macquarie, New South Wales

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    Wahroonga, New South Wales, 2076

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Wodonga, Victoria, 3690

  • Study site

    Wooloongabba, Queensland, 4102

Other trials in Australia

Canada14 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Halifax, Nova Scotia, B3H 1V7

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    Kingston, Ontario, K7L 5P9

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Saskatoon, Saskatchewan, S7N 4H4

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2N2

  • Study site

    Vancouver, British Columbia, V5Z 4E6

  • Study site

    Winnepeg, Manitoba, R3A 1R9

Other trials in Canada

Spain13 sites

  • Study site

    Badalona, Catalonia, 08003

  • Study site

    Barcelona, Catalonia, 08025

  • Study site

    Barcelona, 08035

  • Study site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28922

  • Study site

    Málaga, Málaga

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Santiago de Compostela, 15706

  • Study site

    Seville, 28050

  • Study site

    Valencia, 46010

Other trials in Spain

United Kingdom12 sites

  • Study site

    Aberdeen, Scotland, AB25 2ZN

  • Study site

    Birmingham, England, B15 2TH

  • Study site

    Derby, England, DE22 3NE

  • Study site

    Edinburgh, Scotland, EH4 2XU

  • Study site

    Glasgow, Scotland

  • Study site

    Guildford, England, GU2 7XX

  • Study site

    London, England, EC1A 7BE

  • Study site

    London, England, SE1 9ER

  • Study site

    London, England

  • Study site

    Manchester, England, M20 4BX

  • Study site

    Metropolitan Borough of Wirral, England, CH63 4JY

  • Study site

    Northwood, England, HA6 2RN

Other trials in United Kingdom

France11 sites

  • Study site

    Besançon, Doubs, 25030

  • Study site

    Bordeaux, Gironde, 33075

  • Study site

    Caen, Calvados, 14076

  • Study site

    Le Mans, Sarthe, 72000

  • Study site

    Lyon, Rhône, 96008

  • Study site

    Marseille, 13273

  • Study site

    Nantes, Loire-Atlantique, 44805

  • Study site

    Paris, 75908

  • Study site

    Rennes, Ille-et-Vilaine, 35042

  • Study site

    Toulouse, Haute-Garonne, 31052

  • Study site

    Villejuif, Val-de-Marne, 94805

Other trials in France

Italy10 sites

  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Bari, Apulia, 70124

  • Study site

    Cremona, Lombardy, Lombardia

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Meldola, Emilia-Romagna, 47014

  • Study site

    Modena, Emilia-Romagna, 41124

  • Study site

    Ravenna, Emilia-Romagna, 48100

  • Study site

    Rome, Lazio, 00128

  • Study site

    Rome, Lazio, 00152

  • Study site

    Terni, Umbria, 05100

Other trials in Italy

Belgium7 sites

  • Study site

    Antwerp, 2020

  • Study site

    Bonheiden, Antwerpen, 2820

  • Study site

    Brasschaat, Antwerpen, 2930

  • Study site

    Brussels, Brussels Capital, 1000

  • Study site

    Leuven, Vlaams Brabant, 3000

  • Study site

    Liège, 4000

  • Study site

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Netherlands4 sites

  • Study site

    Amsterdam, North Holland, 1066 CX

  • Study site

    Leiden, South Holland, 2333 ZA

  • Study site

    Maastricht, Limburg, 6229 HX

  • Study site

    Rotterdam, South Holland, 3045 PM

Other trials in Netherlands

Poland4 sites

  • Study site

    Bialystok, Podlaskie Voivodeship, 15-027

  • Study site

    Gdansk, Pomeranian Voivodeship, 80-210

  • Study site

    Poznan, Greater Poland Voivodeship, 60-569

  • Study site

    Warsaw, 04-909

Other trials in Poland

Russia4 sites

  • Study site

    Moscow, 115478

  • Study site

    Omsk, 644013

  • Study site

    Saint Petersburg, 196247

  • Study site

    Yaroslavl, 150040

Other trials in Russia

Turkey (Türkiye)4 sites

  • Study site

    Ankara, 6500

  • Study site

    Gaziantep, 27100

  • Study site

    Istanbul, 34365

  • Study site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Austria3 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1100

Other trials in Austria

Czechia3 sites

  • Study site

    Brno, 656 91

  • Study site

    Olomouc, Olomouc Region, 775 20

  • Study site

    Prague, 128 08

Other trials in Czechia

Denmark3 sites

  • Study site

    Aarhus, Central Jutland, DK-8000

  • Study site

    Herlev, Capital Region, DK-2730

  • Study site

    Odense, Region Syddanmark, DK-5000

Other trials in Denmark

Portugal3 sites

  • Study site

    Lisbon, 1500-650

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 200-072

Other trials in Portugal

South Korea3 sites

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul

Other trials in South Korea

Sweden3 sites

  • Study site

    Lund, Skåne County, SE-22185

  • Study site

    Stockholm, Södermanland County

  • Study site

    Umeå

Other trials in Sweden

Argentina2 sites

  • Study site

    La Plata, Buenos Aires, B1900BAJ

  • Study site

    Mar del Plata, B7600LTO

Other trials in Argentina

Finland2 sites

  • Study site

    Helsinki, 290

  • Study site

    Turku, Länsi-Suomen Lääni, FI-20520

Other trials in Finland

Hungary2 sites

  • Study site

    Budapest, 1122

  • Study site

    Szolnok, 5004

Other trials in Hungary

Ireland2 sites

  • Study site

    Dublin, 24

  • Study site

    Dublin, 7

Other trials in Ireland

Slovakia2 sites

  • Study site

    Prešov, 08001

  • Study site

    Žilina, 01207

Other trials in Slovakia

Taiwan2 sites

  • Study site

    Taichung

  • Study site

    Taipei

Other trials in Taiwan

Chile1 site

  • Study site

    Santiago

Other trials in Chile

About this study

Official title: A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

Being tested
Cabozantinib tablets, Everolimus (Afinitor) tablets
Keywords
renal cell cancer, kidney, vascular endothelial growth factor receptor 2 (VEGFR2), tyrosine kinase inhibitor, hepatocyte growth factor receptor protein (MET), von Hippel-Lindau gene
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • Cabozantinib tabletsDrug

    Also called XL184

  • Everolimus (Afinitor) tabletsDrug

Study groups in NCT01865747
Study groupRoleWhat they receive
Cabozantinib (XL184)ExperimentalCabozantinib (XL184) 60 mg tablet once daily.
Receives: Drug: Cabozantinib tablets
Everolimus (Afinitor)Active comparatorEverolimus (Afinitor) 10 mg tablet once daily.
Receives: Drug: Everolimus (Afinitor) tablets

What is being measured

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

  1. Progression-free Survival (PFS)

    The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.

    Measured: PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.

Secondary outcomes (2)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).

    Measured: OS was measured from the time of randomization until 320 deaths, approximately 28 months

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit >= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.

    Measured: ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)

Timeline

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

  1. First posted31 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion22 May 2015
  4. Study completion15 Jan 2021

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
658 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865747
Sponsor's protocol ID
XL184-308
Acronym
METEOR
Status last verified
Apr 2021
First submitted
21 May 2013
Last updated
27 Apr 2021
Data monitoring committee
Yes

Publications

  • Gong AJ, Ruchalski K, Kim HJ, Douek M, Gutierrez A, Patel M, Sai V, Coy H, Villegas B, Raman S, Goldin J. RECIST 1.1 Target Lesion Categorical Response in Metastatic Renal Cell Carcinoma: A Comparison of Conventional versus Volumetric Assessment. Radiol Imaging Cancer. 2023 Sep;5(5):e220166. doi: 10.1148/rycan.220166.

    PubMed 37656041

  • Denize T, Farah S, Cimadamore A, Flaifel A, Walton E, Sticco-Ivins MA, Labaki C, Braun DA, Sun M, Wang E, Xie W, Choueiri TK, Signoretti S. Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial. Clin Cancer Res. 2022 Feb 15;28(4):748-755. doi: 10.1158/1078-0432.CCR-21-3088.

    PubMed 34921022

  • Powles T, Choueiri TK, Motzer RJ, Jonasch E, Pal S, Tannir NM, Signoretti S, Kaldate R, Scheffold C, Wang E, Aftab DT, Escudier B, George DJ. Outcomes based on plasma biomarkers in METEOR, a randomized phase 3 trial of cabozantinib vs everolimus in advanced renal cell carcinoma. BMC Cancer. 2021 Aug 7;21(1):904. doi: 10.1186/s12885-021-08630-w.

    PubMed 34364385

  • Donskov F, Motzer RJ, Voog E, Hovey E, Grullich C, Nott LM, Cuff K, Gil T, Jensen NV, Chevreau C, Negrier S, Depenbusch R, Bergmann L, Cornelio I, Champsaur A, Escudier B, Pal S, Powles T, Choueiri TK. Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma. Eur J Cancer. 2020 Feb;126:1-10. doi: 10.1016/j.ejca.2019.10.032. Epub 2019 Dec 27.

    PubMed 31887537

  • Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.

    PubMed 31371341

  • Cella D, Escudier B, Tannir NM, Powles T, Donskov F, Peltola K, Schmidinger M, Heng DYC, Mainwaring PN, Hammers HJ, Lee JL, Roth BJ, Marteau F, Williams P, Baer J, Mangeshkar M, Scheffold C, Hutson TE, Pal S, Motzer RJ, Choueiri TK. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. J Clin Oncol. 2018 Mar 10;36(8):757-764. doi: 10.1200/JCO.2017.75.2170. Epub 2018 Jan 29.

    PubMed 29377755

  • Escudier B, Powles T, Motzer RJ, Olencki T, Aren Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.

    PubMed 29309249

  • Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.

    PubMed 27279544

  • Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.

    PubMed 26406150

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabozantinib tablets and Everolimus (Afinitor) tablets in people with Renal Cell Carcinoma, run by Exelixis at 205 sites in 26 countries.

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

Who may be eligible to take part?

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 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Germany, Australia, Canada, Spain and 21 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 18 Jul 2017). 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) (time frame: PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.). 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 NCT01865747, which also lists 9 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 2021.

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