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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01865747
Recruitment Status : Active, not recruiting
First Posted : May 31, 2013
Results First Posted : July 18, 2017
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Cabozantinib tablets Drug: Everolimus (Afinitor) tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2013
Actual Primary Completion Date : May 22, 2015
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily.
Drug: Cabozantinib tablets
Other Name: XL184

Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily.
Drug: Everolimus (Afinitor) tablets

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01865747

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Alaska
Anchorage, Alaska, United States, 99503
United States, Arizona
Gilbert, Arizona, United States, 85234
Scottsdale, Arizona, United States, 85259
Tucson, Arizona, United States, 85724
United States, 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
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, 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
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Westwood, Kansas, United States, 66205
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
Albany, New York, United States, 12206
New York, New York, United States, 10065
United States, North Carolina
Durham, North Carolina, United States, 22710
United States, Ohio
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Oregon
Portland, Oregon, United States, 97213
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Knoxville, Tennessee, United States, 37920
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37232
United States, 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, 77024
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle, Washington, United States, 98109
Vancouver, Washington, United States, 98684
Yakima, Washington, United States, 98902
La Plata, Buenos Aires, Argentina, B1900BAJ
Mar Del Plata, Argentina, B7600LTO
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
Australia, Queensland
Milton, Queensland, Australia, 4064
Wooloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Bentleight East, Victoria, Australia, 3165
Box Hill, Victoria, Australia, 3128
Wodonga, Victoria, Australia, 3690
Linz, Oberösterreich, Austria, 4010
Wien, Austria, 1090
Wien, Austria, 1100
Bonheiden, Antwerpen, Belgium, 2820
Brasschaat, Antwerpen, Belgium, 2930
Bruxelles, Brussels, Belgium, 1000
Leuven, Vlaams Brabant, Belgium, 3000
Roeselare, West-Vlaanderen, Belgium, 8800
Antwerpen, Belgium, 2020
Liege, Belgium, 4000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Winnepeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, 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
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Santiago, Chile
Olomouc, Olomoucký Kraj, Czechia, 775 20
Brno, Czechia, 656 91
Prague, Czechia, 128 08
Herlev, Hovedstaden, Denmark, DK-2730
Aarhus, Midtjylland, Denmark, DK-8000
Odense, Syddanmark, Denmark, DK-5000
Turku, Länsi-Suomen Lääni, Finland, FI-20520
Helsinki, Finland, 290
Caen, Calvados, France, 14076
Besancon, Doubs, France, 25030
Bordeaux, Gironde, France, 33075
Toulouse, Haute-Garonne, France, 31052
Rennes, Ille-et-Vilaine, France, 35042
Nantes, Loire-Atlantique, France, 44805
Lyon, Rhône, France, 96008
Le Mans, Sarthe, France, 72000
Villejuif, Val-de-Marne, France, 94805
Marseille, France, 13273
Paris, France, 75908
Freiburg, Baden Wuttemberg, Germany, 79106
Tubingen, Baden-Württemberg, Germany, 72076
Ulm, Baden-Württemberg, Germany, 89075
Erlangen, Bayern, Germany, 91054
Aachen, Nordrhein-Westfalen, Germany, 52074
Essen, Nordrhein-Westfalen, Germany, 45122
Mainz, Rheinland-Pfalz, Germany, 55131
Jena, Thuringen, Germany, 99089
Erfurt, Thüringen, Germany, 99089
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
Budapest, Hungary, 1122
Szolnok, Hungary, 5004
Dublin, Ireland, 24
Dublin, Ireland, 7
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41124
Ravenna, Emilia-Romagna, Italy, 48100
Rome, Lazio, Italy, 00128
Rome, Lazio, Italy, 00152
Genova, Liguria, Italy, 16132
Cremona, Lombardia, Italy, Lombardia
Bari, Puglia, Italy, 70124
Arezzo, Toscana, Italy, 52100
Terni, Umbria, Italy, 05100
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of
Maastricht, Limburg, Netherlands, 6229 HX
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Rotterdam, Zuid-Holland, Netherlands, 3045 PM
Bialystok, Podlaskie, Poland, 15-027
Gdansk, Pomorskie, Poland, 80-210
Poznan, Wielkopolskie, Poland, 60-569
Warsaw, Poland, 04-909
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
Presov, Slovakia, 08001
Zilina, Slovakia, 01207
Oviedo, Asturias, Spain, 33006
Barcelona, Cataluna, Spain, 08025
Badalona, Cataluña, Spain, 08003
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Pamplona, Navarra, Spain, 31008
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
Lund, Skane Lan, Sweden, SE-22185
Stockholm, Sodermanlands Lan, Sweden
Umea, Sweden
Taichung, Taiwan
Taipei, Taiwan
Ankara, Turkey, 6500
Gaziantep, Turkey, 27100
Istanbul, Turkey, 34365
Izmir, Turkey, 35100
United Kingdom
Birmingham, England, United Kingdom, B15 2TH
Derby, England, United Kingdom, DE22 3NE
Guildford, England, United Kingdom, GU2 7XX
London, England, United Kingdom, EC1A 7BE
London, England, United Kingdom, SE1 9ER
London, England, United Kingdom
Manchester, England, United Kingdom, M20 4BX
Northwood, England, United Kingdom, HA6 2RN
Wirral, England, United Kingdom, CH63 4JY
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Edinburgh, Scotland, United Kingdom, EH4 2XU
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Exelixis Identifier: NCT01865747     History of Changes
Other Study ID Numbers: XL184-308
First Posted: May 31, 2013    Key Record Dates
Results First Posted: July 18, 2017
Last Update Posted: May 22, 2018
Last Verified: April 2018

Keywords provided by Exelixis:
renal cell cancer
vascular endothelial growth factor receptor 2 (VEGFR2)
tyrosine kinase inhibitor
hepatocyte growth factor receptor protein (MET)
von Hippel-Lindau gene

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents