A Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma

December 5, 2008 updated by: Eisai Limited

A Randomized, Placebo-Controlled, Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma

The purpose of this study is to determine the superiority of inhibitory effects and safety of Menatetrenone (E0167) on recurrence in patients with hepatocellular carcinoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study was conducted as a multicenter, randomized, parallel, placebo-controlled, double-blind comparative clinical study. Patients were randomly assigned in a double-blind manner to receive 45 or 90 mg/day of oral vitamin K2 or an identical-appearing placebo. Study drug was administered orally three times daily after meals until recurrence.

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Phase 2
  • 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
    • Fukuoka-prefecture
      • Fukuoka, Fukuoka-prefecture, Japan, 814-0133
      • Kurume, Fukuoka-prefecture, Japan, 830-0011
    • Hiroshima-prefecture
      • Naka, Hiroshima-prefecture, Japan, 730-001
    • Hokkaido-prefecture
      • Sapporo, Hokkaido-prefecture, Japan, 006-8111
      • Sapporo, Hokkaido-prefecture, Japan, 060-0033
    • Ibaraki-prefecture
      • Hitachi, Ibaraki-prefecture, Japan, 317-0077
    • Iwate-prefecture
      • Morioka, Iwate-prefecture, Japan, 020-0023
    • Kanagawa-prefecture
      • Kawasaki, Kanagawa-prefecture, Japan, 213-0001
    • Kanazawa-prefecture
      • Kanazawa, Kanazawa-prefecture, Japan, 920-0934
    • Miyagi-prefecture
      • Senndai, Miyagi-prefecture, Japan, 980-0872
    • Niigata-prefecture
      • Niigata, Niigata-prefecture, Japan, 951-8122
    • Oita-prefecture
      • Oita, Oita-prefecture, Japan, 879-5503
    • Okayama-prefecture
      • Kurashiki, Okayama-prefecture, Japan, 710-0052
      • Okayama, Okayama-prefecture, Japan, 700-0013
      • Okayama, Okayama-prefecture, Japan, 700-0014
    • Osaka-prefecture
      • Moriguchi, Osaka-prefecture, Japan, 570-0074
      • Osaka, Osaka-prefecture, Japan, 537-0025
      • Osaka, Osaka-prefecture, Japan, 543-0021
      • Osaka, Osaka-prefecture, Japan, 543-0027
      • Osakasayama, Osaka-prefecture, Japan, 589-0014
    • Saga-prefecture
      • Saga, Saga-prefecture, Japan, 840-0054
      • Saga, Saga-prefecture, Japan, 849-0937
    • Shizuoka-prefecture
      • Shizuoka, Shizuoka-prefecture, Japan, 420-0881
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0033
      • Chiyoda-ku, Tokyo, Japan, 101-0024
      • Setagaya-ku, Tokyo, Japan, 158-0098
      • Shibuya-ku, Tokyo, Japan, 151-0053
      • Shinjuku-ku, Tokyo, Japan, 162-0052
    • Wakayama-prefecture
      • Wakayama, Wakayama-prefecture, Japan, 641-0012
    • Yamaguchi-prefecture
      • Ube, Yamaguchi-prefecture, Japan, 755-0046

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:

  1. 20 years or older at the time of obtaining consent.
  2. Systemic conditions are 0 to 2 score of Performance Status (according to Eastern Cooperative Oncology Group: ECOG).

  3. Diagnosis of hepatocellular carcinoma is based on the following 1) or 2).

    • 1) Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging
    • 2) Patients who underwent tumor biopsy and are histopathologically diagnosed as hepatocellular carcinoma
  4. Primary onset or recurrence of hepatocellular carcinoma is not more than 1 time.

  5. Patients who underwent the following 1) or 2) within 90 days prior to registration to determine therapeutic effect.

    • 1) Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI.
    • 2) Patients who underwent surgical treatment(s) and are confirmed not to have residual tumor with CT or MRI imaging.

  6. Patients who meet the following items to determine liver function:

    • 1) Albumin is 2.8 g/dL or above
    • 2) Total bilirubin is under 2.0 mg/dL
    • 3) Prothrombin activation is 40% or above
  7. Patients who are given full explanation of study participation (including cancer notification) and submit written consent forms with their understanding as well as voluntary will for this study.

Exclusion Criteria:

  1. Hepatocellular carcinoma:

    • 1) Patients who have extrahepatic metastasis
    • 2) Patients who have portal invasion
    • 3) Patients who experienced with systemic administration of anti-malignant tumor drugs to treat hepatocellular carcinoma
    • 4) Patients treated with transcatheter arterial chemoembolization (TAE) alone as a non-local therapy for hepatocellular carcinoma

  2. Hepatitis:

    -- 1) Patients of (a) or (b) previously treated with interferon preparations (including clinical studies).

    • (a) Patients with chronic hepatitis C virus (HCV) showing HCV-RNA negative
    • (b) Patients with viral hepatitis treated with interferon preparations within the last 2 years (from the same day, 6 months earlier to the day of obtaining consent forms)
    • (c) Patients with encephalopathy in which pharmacotherapy is ineffective
    • (d) Patients with ascites or pleural effusion that cannot be managed with diuretics

  3. Systemic conditions:

    • 1) Patients unable to receive oral administration
    • 2) Patients with a history of gastrectomy or extensive resection of digestive tract
    • 3) Patients who are suspected to have biliary occlusion, choleretic disorder, cholecystectomy, or malabsorption of liposoluble agents
    • 4) Patients with complicated serious diseases such as cardiovascular (e.g., myocardial infarction), hematological (e.g., aplastic anemia), and/or renal dysfunctions (e.g., acute and chronic renal failure)
    • 5) Patients with multiple cancers (within a 5-year cancer-free period [from the same day of 5 years earlier to the day of obtaining consent forms])

  4. Drug administration:

    • 1) Patients on warfarin potassium therapy
    • 2) Patients with a known history of drug allergy to E0167 or its ingredients
    • 3) Patients who received vitamin K preparations within the recent 6 months (from the same day of 6 month earlier to the day of obtaining consent forms)

  5. Other exclusion criteria

    • 1) Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant
    • 2) Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)
    • 3) Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Menatetrenone
45 mg capsule, orally, three times a day, after meals.
Other Names:
  • E0167
Drug: Menatetrenone
90 mg capsule, orally, three times a day, after meals.
Other Names:
  • E0167
Experimental: 2
Drug: Menatetrenone
45 mg capsule, orally, three times a day, after meals.
Other Names:
  • E0167
Drug: Menatetrenone
90 mg capsule, orally, three times a day, after meals.
Other Names:
  • E0167
Placebo Comparator: 3
Drug: Placebo
Placebo capsule, orally, three times a day, after meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival period.
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

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

Sponsor

Eisai Limited

Investigators

  • Study Director: Nozomu Koyanagi, Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center

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

March 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 9, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0167-J081-551

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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