Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

November 26, 2013 updated by: Bayer
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

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

  • Japan
      • Chiba, Japan, 260-8677
      • Fukui, Japan, 918-8503
      • Fukuoka, Japan, 814-0180
      • Gifu, Japan, 500-8513
      • Hiroshima, Japan, 734-8530
      • Hiroshima, Japan, 734-8551
      • Hiroshima, Japan, 730-8619
      • Kagoshima, Japan, 890-8520
      • Kagoshima, Japan, 890-0061
      • Kagoshima, Japan, 892-8512
      • Kumamoto, Japan, 860-0008
      • Kumamoto, Japan, 861-4193
      • Kumamoto, Japan, 860-8556
      • Kyoto, Japan, 606-8507
      • Miyazaki, Japan, 880-0003
      • Okayama, Japan, 700-8511
      • Osaka, Japan, 530-8480
      • Osaka, Japan, 540-0006
      • Osaka, Japan, 558-8558
      • Osaka, Japan, 534-0021
      • Osaka, Japan, 537-8511
      • Osaka, Japan, 543-8555
      • Osaka, Japan, 545-8586
      • Toyama, Japan, 930-8550
      • Yamagata, Japan, 990-9585
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
      • Toon, Ehime, Japan, 791-0295
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
      • Kitakyushu, Fukuoka, Japan, 807-8555
      • Kitakyushu, Fukuoka, Japan, 802-8533
      • Kurume, Fukuoka, Japan, 830-0011
    • Gunma
      • Isesaki, Gunma, Japan, 372-0817
      • Maebashi, Gunma, Japan, 371-8511
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0193
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
      • Sapporo, Hokkaido, Japan, 003-0804
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
      • Kobe, Hyogo, Japan, 650-0017
    • Ibaraki
      • Kasama, Ibaraki, Japan, 309-1793
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
      • Sagamihara, Kanagawa, Japan, 228-8520
      • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama, Kanagawa, Japan, 245-8575
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
      • Sendai, Miyagi, Japan, 980-8574
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
    • Nagasaki
      • Omura, Nagasaki, Japan, 856-8562
    • Osaka
      • Kawachinagano, Osaka, Japan, 586-8521
      • Moriguchi, Osaka, Japan, 570-8507
      • Osakasayama, Osaka, Japan, 589-8511
      • Suita, Osaka, Japan, 565-0871
    • Shizuoka
      • Izunokuni, Shizuoka, Japan, 410-2295
      • Sunto, Shizuoka, Japan, 411-8777
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
      • Itabashi-ku, Tokyo, Japan, 173-8610
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Minato-ku, Tokyo, Japan, 105-8470
      • Musashino, Tokyo, Japan, 180-8610
      • Nerima-ku, Tokyo, Japan, 177-8521
      • Shinjuku-ku, Tokyo, Japan, 160-0023
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-0061
      • Ube, Yamaguchi, Japan, 755-8505
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
      • Incheon, Korea, Republic of, 405-760
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 135710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 152-703

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

All

Description

Inclusion Criteria:

  • Male or female
  • Aged of 18 and over
  • Advanced hepatocellular carcinoma

Exclusion Criteria:

  • History of prior systemic chemotherapy
  • Failure in vital organ

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
Drug: Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo Comparator: Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Drug: Placebo
Placebo: matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization of the first subject until 39 months later.
Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.
From randomization of the first subject until 39 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

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

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

April 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

June 29, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11721

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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