- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605227
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)
February 14, 2018 updated by: Exelixis
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100
This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1028
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
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New South Wales
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Albury, New South Wales, Australia, 2640
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Concord, New South Wales, Australia, 2193
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Darlinghurst, New South Wales, Australia, 2010
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Kogarah, New South Wales, Australia, 2217
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Port Macquarie, New South Wales, Australia, 2444
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Randwick, New South Wales, Australia, 2031
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Wahroonga, New South Wales, Australia, 2076
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Westmead, New South Wales, Australia, 2145
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Queensland
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South Brisbane, Queensland, Australia, 4101
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Southport, Queensland, Australia, 4215
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Woolloongabba, Queensland, Australia, 4102
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South Australia
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Adelaide, South Australia, Australia, 5000
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Kurralta Park, South Australia, Australia, 5037
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Tasmania
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Hobart, Tasmania, Australia, 7000
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Victoria
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Bentleigh East, Victoria, Australia, 3165
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Box Hill, Victoria, Australia, 3128
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Wodonga, Victoria, Australia, 3690
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Western Australia
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Perth, Western Australia, Australia, 6000
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Linz, Austria, 4010
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Salzburg, Austria, 5020
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Wein, Austria, 1100
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Wien, Austria, 1090
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Aalst, Belgium, 9300
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Bonheiden, Belgium, 2820
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Brussels, Belgium, 1000
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Brussels, Belgium, 1090
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Brussels, Belgium, 1200
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Gent, Belgium, 9000
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Hasselt, Belgium, 3500
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Leuven, Belgium, B-3000
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Liège, Belgium, 4000
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Roeselare, Belgium, 8800
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Quebec, Canada, G1R 2J6
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
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New Brunswick
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Miramichi, New Brunswick, Canada, E1V 1Y3
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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London, Ontario, Canada, N6A 4L6
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Owen Sound, Ontario, Canada, N4K 2J1
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Quebec
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Montreal, Quebec, Canada, H2L4M1
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Angers, France, 49933
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Besançon, France, 25030
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Bordeaux, France, 33076
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Caen, France, 14076
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Clermont Ferrand, France, 63011
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Dijon, France, 21079
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La Roche sur Yon, France, 85925
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Le Mans, France, 72000
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Lille, France, 59000
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Lyon Cedex 08, France, 69373
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Marseille, France, 13273
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Nancy, France, 54100
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Paris, France, 75014
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Paris, France, 75015
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Paris, France, 75010
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Paris, France, 75005
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Paris, France, 75230
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Pierre Benite, France, 69495
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Rennes, France, 35042
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Saint Herblain, France, 44805
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Strasbourg, France, 67000
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Suresnes, France, 92151
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Villejuif Cedex, France, 94805
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Aachen, Germany, 52074
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Aachen, Germany, 52062
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Berlin, Germany, 12200
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Berlin, Germany, 13055
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Braunschweig, Germany, 38126
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Dresden, Germany, 01307
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Dusseldorf, Germany, 40225
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Frankfurt am Main, Germany, 60488
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Freiburg, Germany, 79106
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Furth, Germany, 90766
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Gütersloh, Germany, 33332
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Hamburg, Germany, 20246
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Hamburg, Germany, 22399
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Hamburg, Germany, 22763
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Homburg, Germany, 66421
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Kassel, Germany, 34125
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Kempen, Germany, 47906
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Kirchheim, Germany, 73230
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Koln, Germany, 50968
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Mannheim, Germany, 68167
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Munchen, Germany, 81675
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Munster, Germany, 48149
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Nurtingen, Germany, 72622
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Offenburg, Germany, 77654
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Traunstein, Germany, 83278
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Tubingen, Germany, 72076
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Weiden, Germany, 92637
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Wuppertal, Germany, 42103
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Cork, Ireland
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Dublin, Ireland, 24
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Dublin, Ireland, 7
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Galway, Ireland
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Ancona, Italy, 60126
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Arezzo, Italy, 52100
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Aviano, Italy, 33081
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Brindisi, Italy, 72100
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Cremona, Italy, 26100
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Genova, Italy, 16132
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Livorno, Italy, 57123
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Meldola, Italy, 47014
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Milano, Italy, 20162
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Milano, Italy, 20132
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Milano, Italy, 20133
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Modena, Italy, 41124
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Napoli, Italy, 80131
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Novara, Italy, 28100
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Orbassano, Italy, 10043
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Padova, Italy, 35128
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Pavia, Italy, 27100
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Pisa, Italy, 56126
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Pordenone, Italy, 33170
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Ravenna, Italy, 48121
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Rimini, Italy, 47900
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Roma, Italy, 00128
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Roma, Italy, 00152
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Rozzano, Italy, 20089
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Terni, Italy, 05100
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Torino, Italy, 10126
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Verona, Italy, 37134
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Amsterdam, Netherlands, 1066 CX
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Groningen, Netherlands, 9713 GZ
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Groningen, Netherlands, 9728 NT
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Hoofddorp, Netherlands, 2134 TM
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Nieuwegein, Netherlands, 3435 CM
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3045 PM
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Rotterdam, Netherlands, 3075 EA
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Tilburg, Netherlands, 5042 AD
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Zwolle, Netherlands, 8025 AB
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Ponce, Puerto Rico, 00716
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Andalucía
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Málaga, Andalucía, Spain, 29010
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Sevilla, Andalucía, Spain, 41013
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Asturias
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Oviedo, Asturias, Spain, 33006
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Baleares
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Palma de Mallorca, Baleares, Spain, 07010
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Canarias
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La Laguna, Canarias, Spain, 38320
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Cataluña
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Badalona, Cataluña, Spain, 08916
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Barcelona, Cataluña, Spain, 08003
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Barcelona, Cataluña, Spain, 08023
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Barcelona, Cataluña, Spain, 08025
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Barcelona, Cataluña, Spain, 08035
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Barcelona, Cataluña, Spain, 08036
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L'Hospitalet de Llobregat, Cataluña, Spain, 08908
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Manresa, Cataluña, Spain, 08243
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Comunidad Valenciana
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Elche, Comunidad Valenciana, Spain, 03016
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Valencia, Comunidad Valenciana, Spain, 46009
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Galicia
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A Coruña, Galicia, Spain, 15006
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Santiago de Compostela, Galicia, Spain, 15706
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Madrid, Communidad De
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Madrid, Madrid, Communidad De, Spain, 28007
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Madrid, Madrid, Communidad De, Spain, 28040
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Madrid, Madrid, Communidad De, Spain, 28041
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Madrid, Madrid, Communidad De, Spain, 28050
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Madrid, Madrid, Communidad De, Spain, 28922
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Majadahonda, Madrid, Communidad De, Spain, 28222
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Navarra
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Pamplona, Navarra, Spain, 31008
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Gotenborg, Sweden, SE 41345
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Malmo, Sweden, SE-20502
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Orebro, Sweden, SE-70185
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Stockholm, Sweden, SE-17176
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Umea, Sweden, SE-90184
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Uppsala, Sweden, SE 75185
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Vaxjo, Sweden, SE-35185
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Aberdeen, United Kingdom, AB25 2ZN
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Bath, United Kingdom, BA1 3NG
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Birmingham, United Kingdom, B15 2TH
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Brighton, United Kingdom, BN2 5BE
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Bristol, United Kingdom, BS2 8ED
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Cambridge, United Kingdom, CB2 2QQ
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Cardiff, United Kingdom, CF14 2TL
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Cottingham, United Kingdom, HU16 5JQ
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Edinburgh, United Kingdom, EH4 2XU
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Inverness, United Kingdom, IV2 3UJ
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Lancaster, United Kingdom, LA1 4RP
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Leeds, United Kingdom, LS9 7TF
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London, United Kingdom, SE1 9RT
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London, United Kingdom, W12 0HS
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Maidstone, United Kingdom, ME16 9QQ
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Northwood, United Kingdom, HA6 2RN
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Plymouth, United Kingdom, PL6 8DH
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Sheffield, United Kingdom, S10 2SJ
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Southampton, United Kingdom, S16 6YD
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Sutton, United Kingdom, SM2 5PT
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Wirral, United Kingdom, CH63 4JY
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Alabama
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Birmingham, Alabama, United States, 35205
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Alaska
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Anchorage, Alaska, United States, 99508
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Arizona
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Phoenix, Arizona, United States, 85016
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Scottsdale, Arizona, United States, 85255
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Tucson, Arizona, United States, 85710
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Arkansas
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Jonesboro, Arkansas, United States, 72401
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California
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Duarte, California, United States, 91010
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Highland, California, United States, 92346
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La Jolla, California, United States, 92093
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Los Angeles, California, United States, 90033
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Montebello, California, United States, 90640
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Orange, California, United States, 92868
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Palo Alto, California, United States, 94301
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Rancho Mirage, California, United States, 92270
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Saint Helena, California, United States, 94574
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San Marcos, California, United States, 92069
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Vallejo, California, United States, 94589
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Colorado
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Aurora, Colorado, United States, 80045
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Connecticut
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New Haven, Connecticut, United States, 06520
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Southington, Connecticut, United States, 06489
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Florida
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Miami Beach, Florida, United States, 33140
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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Tampa, Florida, United States, 33612
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Titusville, Florida, United States, 32796
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Wellington, Florida, United States, 33449
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West Palm Beach, Florida, United States, 33401
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Georgia
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Athens, Georgia, United States, 30607
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Atlanta, Georgia, United States, 30318
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Marietta, Georgia, United States, 30060
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Illinois
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Galesburg, Illinois, United States, 61401
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Niles, Illinois, United States, 60714
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Iowa
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Ames, Iowa, United States, 50010
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Sioux City, Iowa, United States, 51101
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Kansas
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Wichita, Kansas, United States, 67214
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Kentucky
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Hazard, Kentucky, United States, 41701
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Louisville, Kentucky, United States, 40202
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Maine
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Brewer, Maine, United States, 04412
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Maryland
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Baltimore, Maryland, United States, 21201
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Bethesda, Maryland, United States, 20817
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Towson, Maryland, United States, 21204
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02118
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Methuen, Massachusetts, United States, 01844
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Michigan
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Detroit, Michigan, United States, 48202
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Wyoming, Michigan, United States, 49509
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Minnesota
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Minneapolis, Minnesota, United States, 55455
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Missouri
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Jefferson City, Missouri, United States, 65109
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Springfield, Missouri, United States, 65804
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Nebraska
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Lincoln, Nebraska, United States, 68506
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Omaha, Nebraska, United States, 68130
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New Jersey
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Hackensack, New Jersey, United States, 07601
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Lawrenceville, New Jersey, United States, 08648
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New York
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Albany, New York, United States, 12208
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Garden City, New York, United States, 11530
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New York, New York, United States, 10065
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North Carolina
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Pinehurst, North Carolina, United States, 28374
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North Dakota
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Bismarck, North Dakota, United States, 58501
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Ohio
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Cincinnati, Ohio, United States, 45219
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Columbus, Ohio, United States, 43221
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Oregon
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Portland, Oregon, United States, 97227
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
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Hershey, Pennsylvania, United States, 17033
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Lancaster, Pennsylvania, United States, 17604
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South Carolina
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Greenville, South Carolina, United States, 29615
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Tennessee
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Chattanooga, Tennessee, United States, 37421
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Texas
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Amarillo, Texas, United States, 79106
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Bedford, Texas, United States, 76022
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Houston, Texas, United States, 77024
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Laredo, Texas, United States, 78041
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San Antonio, Texas, United States, 78217
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Utah
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Salt Lake City, Utah, United States, 84112
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Vermont
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Burlington, Vermont, United States, 05405
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Virginia
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Fairfax, Virginia, United States, 22031
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Newport News, Virginia, United States, 23601
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Washington
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Spokane, Washington, United States, 99204
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Wisconsin
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Green Bay, Wisconsin, United States, 54311
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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
Male
Description
Inclusion Criteria:
- Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).
- Evidence of bone metastasis related to prostate cancer on bone scans.
- Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.
- Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
- Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.
- Adequate organ and marrow function.
- Capable of understanding and complying with the protocol requirements and signed the informed consent form.
- Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.
Exclusion Criteria:
- Prior treatment with cabozantinib.
- Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
- Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.
- Known brain metastases or cranial epidural disease.
- Requires concomitant treatment, in therapeutic doses, with anticoagulants.
- Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).
- Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
- Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
- Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
- QTcF > 500 ms within 7 days of randomization.
- Unable to swallow capsules or tablets.
- Previously-identified allergy or hypersensitivity to components of the study treatment formulations.
- Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
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Tablets taken orally once-daily
Other Names:
|
Active Comparator: prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
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Taken twice a day orally.
Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: OS was measured from the time of randomization until 614 events, approximately 24 months after study start
|
The primary analysis of OS is defined as the time from randomization to death due to any cause.
Participants that had not died or were permanently lost to follow-up were censored at the last known date alive.
Median OS was calculated using Kaplan-Meier estimates.
Analysis for OS was performed after 614 events had occurred.
|
OS was measured from the time of randomization until 614 events, approximately 24 months after study start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Scan Response (BSR)
Time Frame: BSR was measured at the end of Week 12 as determined by the IRF
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BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline.
Confirmation of bone scan was not required for response or progression.
Bone scans were evaluated by an independent radiology facility (IRF) for response.
|
BSR was measured at the end of Week 12 as determined by the IRF
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months
|
The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death.
PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions.
A Kaplan-Meier analysis was performed to estimate the median duration.
|
Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
- Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bogemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houede N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.
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
July 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
May 22, 2012
First Submitted That Met QC Criteria
May 23, 2012
First Posted (Estimate)
May 24, 2012
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- XL184-307
- 2012-001834-33 (EudraCT Number)
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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