Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Kowa Company, Ltd.
Sponsor:
Information provided by (Responsible Party):
Kowa Company, Ltd.
ClinicalTrials.gov Identifier:
NCT01640808
First received: July 10, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.


Condition Intervention Phase
Hepatic Neoplasm Malignant Recurrent
Drug: NIK-333(peretinoin)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NIK-333 (Peretinoin) Phase ⅢStudy Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus (HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study

Resource links provided by NLM:


Further study details as provided by Kowa Company, Ltd.:

Primary Outcome Measures:
  • Recurrence-free survival

Estimated Enrollment: 600
Study Start Date: April 2012
Arms Assigned Interventions
Experimental: NIK-333(peretinoin) Drug: NIK-333(peretinoin)
600mg (8 x 75mg tablets) orally, twice a day, continuously until recurrence of HCC, the patient's death, or termination or discontinuation of the entire study.
Placebo Comparator: Placebo Drug: Placebo
600mg (8 x 75mg tablets) orally, twice a day, continuously until recurrence of HCC, the patient's death, or termination or discontinuation of the entire study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with HCV-positive HCC who meet the following conditions before radical treatment

    • Patients diagnosed as having typical HCC on dynamic CT,CTA/CTAP, or dynamic MRI (nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal and equilibrium phases) performed within 8 weeks (56 days) before treatment start prior to radical therapy
    • Patients with the first primary HCC or the first recurrence of primary HCC
  2. Patients who received the radical therapies. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies.
  3. Patients showing a complete cure, as confirmed by the dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure.
  4. Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
  5. Patients confirmed of satisfying the following conditions based on the screening performed at subject registration

    • Positive for serum hepatitis C virus nucleic acid (HCV-RNA)
    • Grade A on Child-Pugh classification
    • Platelet count of 50 000/µL or higher
  6. Patients with ECOG Performance Status score of 0 to 1
  7. Patients of the age of 20 years or older at the time of informed consent

Exclusion Criteria:

  1. Patients positive for HBs antigen
  2. Patients showing vascular invasion of HCC on imaging diagnosis
  3. Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy
  4. Patients who want to receive antiviral therapy such as interferon during the study period
  5. Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy
  6. Patients who have hypertension as a complication, and whose blood pressure cannot be controlled by drug therapy (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, as determined at subject registration)
  7. Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator
  8. Patients with a history of total gastrectomy
  9. Patients with a history of cardiac arrest
  10. Patients with any of the following laboratory values or complications

    • Creatinine>= 1.5mg/dL
    • Albumin urine >= 1000mg/g Creatinine
    • Cardiac disorder corresponding to CTC-AE grade 3 in severity
    • HbA1c >= 7.4 under treatment with insulin
    • Autoimmune disease or asthma being treated with oral steroid
  11. Patients confirmed of having another malignant neoplasm or who had undergone a radical therapy of HCC within the past 5 years to treat another malignant neoplasm (however, this does not apply to endoscopic resection and resection of intraepithelial carcinoma)
  12. Patients who are pregnant, who have a possibility of being pregnant or who have a desire to become pregnant during the study period
  13. Lactating women
  14. Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.) in the past
  15. Patients who participated in another clinical study within past 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640808

Contacts
Contact: Kazuhide Shimada ctrdinfo@kowa.co.jp

  Hide Study Locations
Locations
Japan
Recruiting
Nagoya, Aichi, Japan, 467-0001
Recruiting
Nagoya, Aichi, Japan, 466-0065
Recruiting
Kashiwa, Chiba, Japan, 277-8577
Recruiting
Matsuyama, Ehime, Japan, 790-0826
Recruiting
Iizuka, Fukuoka, Japan, 820-0018
Recruiting
Kurume, Fukuoka, Japan, 830-0011
Recruiting
Ogaki, Gifu, Japan, 503-0864
Recruiting
Sapporo, Hokkaido, Japan, 006-8555
Recruiting
Sapporo, Hokkaido, Japan, 060-0033
Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Recruiting
Himeji, Hyogo, Japan, 670-0063
Recruiting
Kobe, Hyogo, Japan, 650-0047
Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Recruiting
Kawasaki, Kanagawa, Japan, 213-8587
Recruiting
Sagamihara, Kanagawa, Japan, 228-8520
Recruiting
Yokohama, Kanagawa, Japan, 241-0815
Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Nankoku, Kochi, Japan, 783-8505
Recruiting
Kurashiki, Okayama, Japan, 701-0192
Recruiting
Ikdeda, Osaka, Japan, 563-8510
Recruiting
Moriguchi, Osaka, Japan, 570-8507
Recruiting
Osakasayama, Osaka, Japan, 589-8511
Recruiting
Sakai, Osaka, Japan, 591-8025
Recruiting
Suita, Osaka, Japan, 565-0871
Recruiting
Iruma, Saitama, Japan, 350-0495
Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Recruiting
Musashino, Tokyo,, Japan, 180-8610
Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Recruiting
Bunkyo-ku, Tokyo, Japan, 113-0021
Recruiting
Bunkyo-ku,, Tokyo, Japan, 113-8519
Recruiting
Chiyoda-ku, Tokyo, Japan, 101-8643
Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Recruiting
Minato-ku, Tokyo, Japan, 105-8470
Recruiting
Ota-ku, Tokyo, Japan, 143-8541
Recruiting
Setagaya-ku, Tokyo, Japan, 158-8531
Recruiting
Shibuya-ku, Tokyo, Japan, 150-8935
Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Recruiting
Shimonoseki, Yamaguchi, Japan, 750-0061
Recruiting
Ube, Yamaguchi, Japan, 755-8505
Recruiting
Kofu, Yamanashi, Japan, 400-8506
Recruiting
Chiba, Japan, 260-0856
Recruiting
Fukuoka, Japan, 810-8563
Recruiting
Fukuoka, Japan, 814-0180
Recruiting
Gifu, Japan, 500-8513
Recruiting
Gifu, Japan, 501-1194
Recruiting
Hiroshima, Japan, 734-8530
Recruiting
Hiroshima, Japan, 734-8551
Recruiting
Kagoshima, Japan, 890-8520
Recruiting
Kumamoto, Japan, 860-0811
Recruiting
Nagasaki, Japan, 852-8501
Recruiting
Niigata, Japan, 950-1104
Recruiting
Oita, Japan, 879-5593
Recruiting
Okayama, Japan, 700-8558
Recruiting
Osaka, Japan, 534-0021
Recruiting
Osaka, Japan, 540-0006
Recruiting
Osaka, Japan, 537-8511
Recruiting
Osaka, Japan, 545-8586
Recruiting
Osaka, Japan, 543-8555
Recruiting
Saga, Japan, 849-8501
Recruiting
Saga, Japan, 840-8571
Recruiting
Tokushima, Japan, 770-8539
Recruiting
Tokushima, Japan, 770-8503
Recruiting
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Kowa Company, Ltd.
  More Information

No publications provided

Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT01640808     History of Changes
Other Study ID Numbers: NIK-333-05
Study First Received: July 10, 2012
Last Updated: September 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Recurrence
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2014