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

April 1, 2021 updated by: Exelixis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

658

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

  • Argentina
      • Mar Del Plata, Argentina, B7600LTO
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900BAJ
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
      • Darlinghurst, New South Wales, Australia, 2010
      • Kogarah, New South Wales, Australia, 2217
      • Port Macquarie, New South Wales, Australia
      • Randwick, New South Wales, Australia, 2031
      • Wahroonga, New South Wales, Australia, 2076
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Milton, Queensland, Australia, 4064
      • Wooloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Bentleight East, Victoria, Australia, 3165
      • Box Hill, Victoria, Australia, 3128
      • Wodonga, Victoria, Australia, 3690
  • Austria
      • Wien, Austria, 1100
      • Wien, Austria, 1090
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
  • Belgium
      • Antwerpen, Belgium, 2020
      • Liege, Belgium, 4000
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
      • Brasschaat, Antwerpen, Belgium, 2930
    • Brussels
      • Bruxelles, Brussels, Belgium, 1000
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3A 1R9
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • Kingston, Ontario, Canada, K7L 5P9
      • London, Ontario, Canada, N6A 4L6
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2N2
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
  • Chile
      • Santiago, Chile
  • Czechia
      • Brno, Czechia, 656 91
      • Prague, Czechia, 128 08
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 775 20
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, DK-2730
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, DK-8000
    • Syddanmark
      • Odense, Syddanmark, Denmark, DK-5000
  • Finland
      • Helsinki, Finland, 290
    • Länsi-Suomen Lääni
      • Turku, Länsi-Suomen Lääni, Finland, FI-20520
  • France
      • Marseille, France, 13273
      • Paris, France, 75908
    • Calvados
      • Caen, Calvados, France, 14076
    • Doubs
      • Besancon, Doubs, France, 25030
    • Gironde
      • Bordeaux, Gironde, France, 33075
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31052
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44805
    • Rhône
      • Lyon, Rhône, France, 96008
    • Sarthe
      • Le Mans, Sarthe, France, 72000
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
  • Germany
      • Berlin, Germany, 12200
      • Dresden, Germany, 01307
      • Frankfurt am Main, Germany, 60590
      • Guetersloh, Germany, 33332
      • Hamburg, Germany, 20246
      • Hannover, Germany, 30605
      • Heidelberg, Germany, 69120
      • Munchen, Germany, 81675
      • Munich, Germany, 81377
    • Baden Wuttemberg
      • Freiburg, Baden Wuttemberg, Germany, 79106
    • Baden-Württemberg
      • Tubingen, Baden-Württemberg, Germany, 72076
      • Ulm, Baden-Württemberg, Germany, 89075
    • Bayern
      • Erlangen, Bayern, Germany, 91054
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Essen, Nordrhein-Westfalen, Germany, 45122
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Thuringen
      • Jena, Thuringen, Germany, 99089
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
  • Hungary
      • Budapest, Hungary, 1122
      • Szolnok, Hungary, 5004
  • Ireland
      • Dublin, Ireland, 24
      • Dublin, Ireland, 7
  • Italy
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
      • Modena, Emilia-Romagna, Italy, 41124
      • Ravenna, Emilia-Romagna, Italy, 48100
    • Lazio
      • Rome, Lazio, Italy, 00128
      • Rome, Lazio, Italy, 00152
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Cremona, Lombardia, Italy, Lombardia
    • Puglia
      • Bari, Puglia, Italy, 70124
    • Toscana
      • Arezzo, Toscana, Italy, 52100
    • Umbria
      • Terni, Umbria, Italy, 05100
  • Korea, Republic of
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
  • Poland
      • Warsaw, Poland, 04-909
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-027
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-210
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-569
  • Portugal
      • Lisbon, Portugal, 1500-650
      • Lisbon, Portugal, 1649-035
      • Porto, Portugal, 200-072
  • Russian Federation
      • Moscow, Russian Federation, 115478
      • Omsk, Russian Federation, 644013
      • St. Petersburg, Russian Federation, 196247
      • Yaroslavl, Russian Federation, 150040
  • Slovakia
      • Presov, Slovakia, 08001
      • Zilina, Slovakia, 01207
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28922
      • Málaga, Spain, Málaga
      • Santiago de Compostela, Spain, 15706
      • Seville, Spain, 28050
      • Valencia, Spain, 46010
    • Asturias
      • Oviedo, Asturias, Spain, 33006
    • Cataluna
      • Barcelona, Cataluna, Spain, 08025
    • Cataluña
      • Badalona, Cataluña, Spain, 08003
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
    • Navarra
      • Pamplona, Navarra, Spain, 31008
  • Sweden
      • Umea, Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, SE-22185
    • Sodermanlands Lan
      • Stockholm, Sodermanlands Lan, Sweden
  • Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
  • Turkey
      • Ankara, Turkey, 6500
      • Gaziantep, Turkey, 27100
      • Istanbul, Turkey, 34365
      • Izmir, Turkey, 35100
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TH
      • Derby, England, United Kingdom, DE22 3NE
      • Guildford, England, United Kingdom, GU2 7XX
      • London, England, United Kingdom
      • London, England, United Kingdom, EC1A 7BE
      • London, England, United Kingdom, SE1 9ER
      • Manchester, England, United Kingdom, M20 4BX
      • Northwood, England, United Kingdom, HA6 2RN
      • Wirral, England, United Kingdom, CH63 4JY
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
      • Glasgow, Scotland, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
    • Arizona
      • Gilbert, Arizona, United States, 85234
      • Scottsdale, Arizona, United States, 85259
      • Tucson, Arizona, United States, 85724
    • California
      • Duarte, California, United States, 91010
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90095
      • Vallejo, California, United States, 94589
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33176
      • Orlando, Florida, United States, 06520
      • Tampa, Florida, United States, 33612
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Westwood, Kansas, United States, 66205
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • Albany, New York, United States, 12206
      • New York, New York, United States, 10065
    • North Carolina
      • Durham, North Carolina, United States, 22710
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78731
      • Bedford, Texas, United States, 76022
      • Dallas, Texas, United States, 75246
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Washington
      • Seattle, Washington, United States, 98109
      • Vancouver, Washington, United States, 98684
      • Yakima, Washington, United States, 98902

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

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily.
Drug: Cabozantinib tablets
Other Names:
  • XL184
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily.
Drug: Everolimus (Afinitor) tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: OS was measured from the time of randomization until 320 deaths, approximately 28 months
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).
OS was measured from the time of randomization until 320 deaths, approximately 28 months
Objective Response Rate (ORR)
Time Frame: 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)
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.
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)

Collaborators and Investigators

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

Sponsor

Exelixis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2013

Primary Completion (Actual)

May 22, 2015

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 1, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-308

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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