- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00105443
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (SHARP)
24. oktober 2014 oppdatert av: Bayer
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
The purpose of the study is: Find out if patients receiving sorafenib will live longer.
Find out if sorafenib has any effect on patient reported outcomes.
Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases.
Determine the pharmacokinetics (PK) in patients with liver cancer.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The following abbreviations were used in the Adverse Event section:
- international normalized ratio (inr)
- Common Terminology Criteria for Adverse Events (ctcae)
- Not Otherwise Specified (nos)
- Gastrointestinal (gi)
- Central nervous system (cns)
- Absolute Neutrophil Count (anc)
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Creatine phosphokinase (cpk)
- Gammaglutamyltransferase (ggt)
- Genitourinary (gu)
- Atrioventricular (av)
Studietype
Intervensjonell
Registrering (Faktiske)
602
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
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Pilar, Buenos Aires, Argentina, B1629AHJ
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Ciudad Auton. de Buenos Aires
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Bueno Aires, Ciudad Auton. de Buenos Aires, Argentina, C1417DTB
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1120AAF
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1145ADP
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Tucuman
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San Miguel de Tucumán, Tucuman, Argentina, T4000HXU
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San Miguel de Tucumán, Tucuman, Argentina, T4000GTB
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New South Wales
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Camperdown, New South Wales, Australia, 2050
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Randwick, New South Wales, Australia, 2031
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Westmead, New South Wales, Australia, 2145
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Victoria
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East Bentleigh, Victoria, Australia, 3165
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Heidelberg, Victoria, Australia, 3084
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Melbourne, Victoria, Australia, 3052
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Brugge, Belgia, 8000
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Bruxelles - Brussel, Belgia, 1070
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Bruxelles - Brussel, Belgia, 1200
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Bruxelles - Brussel, Belgia, 1090
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Gent, Belgia, 9000
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Leuven, Belgia, 3000
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Belo Horizonte, Brasil, 30380490
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Belo Horizonte, Brasil, 30180090
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Sao Paulo, Brasil, 01246-903
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90619900
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-003
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1527
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Stara Zagora, Bulgaria, 6000
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Varna, Bulgaria, 9010
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
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Edmonton, Alberta, Canada, T6G 2C8
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1H8
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
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Ontario
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London, Ontario, Canada, N6A 5A5
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Ottawa, Ontario, Canada, K1H 1C4
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Toronto, Ontario, Canada, M5G 2N2
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Santiago Región Metropolitana, Chile
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Santiago de Chile, Chile
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Santiago
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Santiago de Chile, Santiago, Chile, 833-0024
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Ekaterinburg, Den russiske føderasjonen, 620102
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Ekaterinburg, Den russiske føderasjonen, 620036
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Kazan, Den russiske føderasjonen, 420012
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Kirov, Den russiske føderasjonen, 610002
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Krasnodar, Den russiske føderasjonen, 350040
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Moscow, Den russiske føderasjonen, 105229
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Moscow, Den russiske føderasjonen, 129110
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Moscow, Den russiske føderasjonen, 115478
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Moscow, Den russiske føderasjonen, 105 203
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Moscow, Den russiske føderasjonen, 111 020
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Moscow, Den russiske føderasjonen, 113 811
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Moscow, Den russiske føderasjonen, 129 010
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St. Petersburg, Den russiske føderasjonen, 197758
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St. Petersburg, Den russiske føderasjonen, 188663
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St. Petersburg, Den russiske føderasjonen, 195 067
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Tolgliatti, Den russiske føderasjonen
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Arizona
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Phoenix, Arizona, Forente stater, 85054-4502
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Tucson, Arizona, Forente stater, 85724
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California
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Los Angeles, California, Forente stater, 90057
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Los Angeles, California, Forente stater, 90095-7077
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Orange, California, Forente stater, 92668-3298
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San Francisco, California, Forente stater, 94121
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Stanford, California, Forente stater, 94305
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Connecticut
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Farmington, Connecticut, Forente stater, 06030
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New Haven, Connecticut, Forente stater, 06510-8019
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Florida
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Gainesville, Florida, Forente stater, 32610
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Miami, Florida, Forente stater, 33136
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Tampa, Florida, Forente stater, 33612
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Georgia
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Atlanta, Georgia, Forente stater, 30308
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Atlanta, Georgia, Forente stater, 30322
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Illinois
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Chicago, Illinois, Forente stater, 60611
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Chicago, Illinois, Forente stater, 60612
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-0362
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Detroit, Michigan, Forente stater, 48202-2689
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Missouri
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St. Louis, Missouri, Forente stater, 63104
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-2000
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New York
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Manhasset, New York, Forente stater, 11030-3876
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New York, New York, Forente stater, 10016
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New York, New York, Forente stater, 10032
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New York, New York, Forente stater, 10021
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New York, New York, Forente stater, 10029
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Ohio
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Canton, Ohio, Forente stater, 44718
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Oregon
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Portland, Oregon, Forente stater, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
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Philadelphia, Pennsylvania, Forente stater, 19140
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Pittsburgh, Pennsylvania, Forente stater, 15213
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Texas
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Houston, Texas, Forente stater, 77030-1502
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Virginia
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Richmond, Virginia, Forente stater, 23249
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Washington
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Seattle, Washington, Forente stater, 98104
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Seattle, Washington, Forente stater, 98195-6174
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Bondy, Frankrike, 93143
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Bordeaux, Frankrike, 33000
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Clichy, Frankrike, 92110
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Dijon, Frankrike, 21000
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Lille Cedex, Frankrike, 59020
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Marseille, Frankrike, 13005
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Nantes, Frankrike, 44805
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Paris, Frankrike, 75020
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Rennes Cedex, Frankrike, 35062
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Vandoeuvre-les-nancy, Frankrike, 54500
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Athens, Hellas, 115 27
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Ioannina, Hellas, 45500
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Thessaloniki, Hellas, 56403
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Thessaloniki, Hellas, 540 07
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Thessaloniki, Hellas, 54639
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Attica
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Haidari, Attica, Hellas, 12462
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Haifa, Israel, 84801
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Petach Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
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Zrifin, Israel, 70300
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Avellino, Italia, 83100
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Bologna, Italia, 40138
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Forlì, Italia, 47100
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Milano, Italia, 20122
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Milano, Italia, 20133
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Padova, Italia, 35128
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Palermo, Italia, 90127
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Pavia, Italia, 27100
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Pisa, Italia, 56126
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Roma, Italia, 00144
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Milano
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Rozzano, Milano, Italia, 20089
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Zagreb, Kroatia, 10000
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Monterrey, Mexico, 64000
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México, D.F., Mexico, 14050
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México, D.F., Mexico, 06720
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Distrito Federal
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México, Distrito Federal, Mexico, 14080
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Auckland, New Zealand, 1023
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Wellington South, New Zealand, 6001
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Comas Lima, Peru
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Lima, Peru, LIMA 34
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Lima Cercado, Peru, LIMA 1
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Gdansk, Polen, 80-952
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Poznan, Polen, 61-878
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Warszawa, Polen, 02-781
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Warszawa, Polen, 02-507
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Craiova Dolj, Romania, 200642
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Iasi, Romania, 700111
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Timis
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Timisoara, Timis, Romania, 300223
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Alicante, Spania, 03010
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Barcelona, Spania, 08036
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Barcelona, Spania, 08003
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Barcelona, Spania, 08035
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Córdoba, Spania, 14004
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Madrid, Spania, 28006
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Madrid, Spania, 28034
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Madrid, Spania, 28041
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Pamplona, Spania, 31008
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Valencia, Spania, 46014
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Barcelona
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Badalona, Barcelona, Spania, 08916
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Bilbao
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Cruces/Barakaldo, Bilbao, Spania, 48903
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London, Storbritannia, SE1 9RT
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London, Storbritannia, NW3 2QG
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Newcastle-upon-Tyne, Storbritannia, NE2 4HH
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Avon
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Bristol, Avon, Storbritannia, BS2 8ED
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Oxfordshire
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Oxford, Oxfordshire, Storbritannia, OX1 2JD
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Stratchclyde
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Glasgow, Stratchclyde, Storbritannia, G11 6NT
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Bern, Sveits, 3010
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Genève, Sveits, 1211
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Zürich, Sveits, 8091
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Sankt Gallen
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St. Gallen, Sankt Gallen, Sveits, 9007
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Berlin, Tyskland, 12200
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Hamburg, Tyskland, 20246
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Tyskland, 79106
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Tübingen, Baden-Württemberg, Tyskland, 72076
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Bayern
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München, Bayern, Tyskland, 81675
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München, Bayern, Tyskland, 81377
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Regensburg, Bayern, Tyskland, 93042
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Hessen
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Frankfurt, Hessen, Tyskland, 60590
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Niedersachsen
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Hannover, Niedersachsen, Tyskland, 30625
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Tyskland, 53105
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Düsseldorf, Nordrhein-Westfalen, Tyskland, 40225
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Essen, Nordrhein-Westfalen, Tyskland, 45122
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Tyskland, 55131
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Saarland
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Homburg, Saarland, Tyskland, 66421
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Sachsen-Anhalt
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Halle, Sachsen-Anhalt, Tyskland, 06120
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Magdeburg, Sachsen-Anhalt, Tyskland, 39120
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Ages eligible for study: 18 years and above, Genders eligible for study: both
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
- Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
- Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- History of cardiac disease
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
|
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
|
Placebo komparator: Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
|
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival (OS)
Tidsramme: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
|
Overall Survival was defined as the time from date of starting treatment to death due to any cause.
Subjects still alive at the time of analysis were censored at their last date of last contact.
|
from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
|
Time to Symptomatic Progression (TTSP)
Tidsramme: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
|
TTSP was defined as the time from randomization to the first documented symptomatic progression.
|
from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to Progression (TTP)
Tidsramme: from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
|
TTP was defined as the time from randomization to disease progression (radiological only).
Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
|
from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
|
Disease Control (DC)
Tidsramme: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
|
The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating.
Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
|
time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
|
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
Tidsramme: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
|
PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire.
The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale.
FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
|
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
- Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4. Erratum In: J Hepatol. 2018 Oct;69(4):990-991.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2005
Primær fullføring (Faktiske)
1. november 2008
Studiet fullført (Faktiske)
1. november 2008
Datoer for studieregistrering
Først innsendt
14. mars 2005
Først innsendt som oppfylte QC-kriteriene
14. mars 2005
Først lagt ut (Anslag)
15. mars 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. oktober 2014
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Karsinom
- Karsinom, hepatocellulært
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Sorafenib
Andre studie-ID-numre
- 100554
- 2004-001773-26 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Sorafenib (Nexavar, BAY43-9006)
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BayerFullførtHepatocellulært karsinomTaiwan
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BayerFullførtBiologisk tilgjengelighetTyskland
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BayerAvsluttetKarsinom, nyrecelleItalia, Spania, Frankrike, Østerrike, Polen, Storbritannia, Irland
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BayerFullførtKarsinom, nyrecelle | Karsinom, hepatocellulærtKorea, Republikken
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BayerFullførtKarsinom, hepatocellulærtJapan
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BayerFullførtKarsinom, nyrecelleBelgia, Italia, Spania, Tyskland, Frankrike, Nederland, Sveits, Polen, Sverige, Storbritannia, Danmark
-
BayerFullført
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BayerFullført