check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

11721

ClinicalTrials.gov Identifier:

NCT00494299

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After transcatheter arterial chemoembolization (TACE)

Trial purpose

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Male or female
    - Aged of 18 and over
    - Advanced hepatocellular carcinoma
  • - History of prior systemic chemotherapy
    - Failure in vital organ

Trial summary

Enrollment Goal
458
Trial Dates
April 2006 - November 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo Kosei General HospitalSapporo, 060-0033, Japan
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Completed
Toranomon HospitalMinato-ku, 105-8470, Japan
Completed
Musashino Red Cross HospitalMusashino, 180-8610, Japan
Completed
Nihon University Itabashi HospitalItabashi-ku, 173-8610, Japan
Completed
Yokohama City Univercity Medical CenterYokohama, 232-0024, Japan
Completed
Kitasato University East HospitalSagamihara, 228-8520, Japan
Completed
Kanazawa University HospitalKanazawa, 920-8641, Japan
Completed
Juntendo University Shizuoka HospitalIzunokuni, 410-2295, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Osaka City University Medical School HospitalOsaka, 545-8586, Japan
Completed
Kitano HospitalOsaka, 530-8480, Japan
Completed
Tottori University HospitalYonago, 683-8504, Japan
Completed
Yamaguchi University HospitalUbe, 755-8505, Japan
Completed
Kagoshima University Medical and Dental HospitalKagoshima, 890-8520, Japan
Completed
Yamagata University HospitalYamagata, 990-9585, Japan
Completed
National Cancer Center HospitalChuo-ku, 104-0045, Japan
Completed
Tokyo Medical University HospitalShinjuku-ku, 160-0023, Japan
Completed
Gifu Municipal HospitalGifu, 500-8513, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Kinki University HospitalOsakasayama, 589-8511, Japan
Completed
Osaka Medical Center for Cancer and Cardiovascular DiseasesOsaka, 537-8511, Japan
Completed
Kansai Medical University Takii HospitalMoriguchi, 570-8507, Japan
Completed
Hiroshima University HospitalHiroshima, 734-8551, Japan
Completed
Shimonoseki Kosei HospitalShimonoseki, 750-0061, Japan
Completed
Ehime University HospitalToon, 791-0295, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Chiba University HospitalChiba, 260-8677, Japan
Completed
Yamaguchi University HospitalUbe, 755-8505, Japan
Completed
Osaka Red Cross HospitalOsaka, 543-8555, Japan
Completed
Tohoku University HospitalSendai, 980-8574, Japan
Completed
Miyazaki Medical Center HospitalMiyazaki, 880-0003, Japan
Completed
Kumamoto University HospitalKumamoto, 860-8556, Japan
Completed
JA Kagoshima Koseiren HospitalKagoshima, 890-0061, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
Nagasaki Medical CenterOmura, 856-8562, Japan
Completed
Shinshu University HospitalMatsumoto, 390-8621, Japan
Completed
Isesaki Municipal HospitalIsesaki, 372-0817, Japan
Completed
Yokohama Medical CenterYokohama, 245-8575, Japan
Completed
Tokai University HospitalIsehara, 259-1193, Japan
Completed
Hiroshima Red Cross & Atomic-bomb Survivors HospitalHiroshima, 730-8619, Japan
Completed
Sendai Medical CenterSendai, 983-8520, Japan
Completed
University of Occupational and Environmental HealthKitakyushu, 807-8555, Japan
Completed
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
Jichi Medical University HospitalShimotsuke, 329-0498, Japan
Completed
University of Yamanashi HospitalChuo, 409-3898, Japan
Completed
Osaka City General HospitalOsaka, 534-0021, Japan
Completed
Shikoku Cancer CenterMatsuyama, 791-0280, Japan
Completed
Osaka National HospitalOsaka, 540-0006, Japan
Completed
Okayama Saiseikai General HospitalOkayama, 700-8511, Japan
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Completed
Fukui Saiseikai HospitalFukui, 918-8503, Japan
Completed
Hokkaido Cancer CenterSapporo, 003-0804, Japan
Completed
Kokura Medical CenterKitakyushu, 802-8533, Japan
Completed
Osaka-Minami Medical CenterKawachinagano, 586-8521, Japan
Completed
Kobe University HospitalKobe, 650-0017, Japan
Completed
Hiroshima Prefectural HospitalHiroshima, 734-8530, Japan
Completed
Saiseikai Kumamoto HospitalKumamoto, 861-4193, Japan
Completed
Chugoku Rousai HospitalKure, 737-0193, Japan
Completed
Aso Iizuka HospitalIizuka, 820-8505, Japan
Completed
Juntendo University Nerima HospitalNerima-ku, 177-8521, Japan
Completed
Nanpuh HospitalKagoshima, 892-8512, Japan
Completed
Toyama Prefectural Central HospitalToyama, 930-8550, Japan
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135710, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, Korea, Republic Of
Completed
Nagoya Medical CenterNagoya, 460-0001, Japan
Completed
Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
Kumamoto Medical CenterKumamoto, 860-0008, Japan
Completed
Hyogo Cancer CenterAkashi, 673-8558, Japan
Completed
Kyungpook National University HospitalDaegu, 700-721, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Gachon University Gil Medical CenterIncheon, 405-760, Korea, Republic Of
Completed
Korea University Guro HospitalSeoul, 152-703, Korea, Republic Of

Primary Outcome

  • Time to Progression (TTP)
    date_rangeTime Frame:
    From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Overall Survial (OS)
    date_rangeTime Frame:
    From randomization of the first subject until 39 months later
    enhanced_encryption
    Safety Issue:
    no

Trial design

Phase III study of BAY43-9006 in patients with advanced hepatocellular carcinoma (HCC) treated after transcatheter arterial chemoembolization (TACE)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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