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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01865747
First received: May 21, 2013
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Drug: Cabozantinib (XL184)
Drug: Everolimus (Afinitor)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]
    PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed for up to 17 months.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    OS is measured from the time of randomization until death due to any cause assessed up to 36 months.

  • Objective Response Rate (ORR) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]
    ORR is the proportion of subjects, assessed up to 17 months, who have measurable disease at baseline and who have complete response (CR) or partial response (PR) at data cut off.


Estimated Enrollment: 650
Study Start Date: June 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) administered as an oral single tablet once daily.
Drug: Cabozantinib (XL184)
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) administered as an oral single tablet once daily.
Drug: Everolimus (Afinitor)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865747

  Hide Study Locations
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, 33176
Miami, Florida, United States, 33136
Orlando, Florida, United States, 06520
Tampa, Florida, United States, 33612
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Westwood, Kansas, United States, 66205
United States, Maryland
Baltimore, Maryland, United States, 21287
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48202
Detroit, Michigan, United States, 48201
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
St. 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, 97239
Portland, Oregon, United States, 97213
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, 37232
Nashville, Tennessee, United States, 37203
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, 77030
Houston, Texas, United States, 77024
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
Argentina
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
Austria
Linz, Oberösterreich, Austria, 4010
Wien, Austria, 1100
Wien, Austria, 1090
Belgium
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
Chile
Santiago, Chile
Czech Republic
Olomouc, Olomoucký kraj, Czech Republic, 775 20
Brno, Czech Republic, 656 91
Prague, Czech Republic, 128 08
Denmark
Herlev, Hovedstaden, Denmark, DK-2730
Aarhus, Midtjylland, Denmark, DK-8000
Odense, Syddanmark, Denmark, DK-5000
Finland
Turku, Länsi-Suomen lääni, Finland, FI-20520
Helsinki, Finland, 290
France
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
Germany
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
Hungary
Budapest, Hungary, 1122
Szolnok, Hungary, 5004
Ireland
Dublin, Ireland, 24
Dublin, Ireland, 7
Italy
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
Seoul, Korea, Republic of, 120-752
Netherlands
Maastricht, Limburg, Netherlands, 6229 HX
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Rotterdam, Zuid-Holland, Netherlands, 3045 PM
Poland
Bialystok, Podlaskie, Poland, 15-027
Gdansk, Pomorskie, Poland, 80-210
Poznan, Wielkopolskie, Poland, 60-569
Warsaw, Poland, 04-909
Portugal
Lisbon, Portugal, 1649-035
Lisbon, Portugal, 1500-650
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
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, 28041
Madrid, Spain, 28922
Madrid, Spain, 28034
Málaga, Spain, Málaga
Santiago de Compostela, Spain, 15706
Seville, Spain, 28050
Valencia, Spain, 46010
Sweden
Lund, Skane lan, Sweden, SE-22185
Stockholm, Sodermanlands lan, Sweden
Umea, Sweden
Taiwan
Taichung, Taiwan
Taipei, Taiwan
Turkey
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
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01865747     History of Changes
Other Study ID Numbers: XL184-308
Study First Received: May 21, 2013
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
renal cell cancer
kidney
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
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014