Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

NCT01640808 | Completed Phase 3 Results

• 1 other identifier: NIK-333-05
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 66

Brief Summary

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.

Conditions

Hepatic Neoplasm Malignant Recurrent

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival

  HCC recurrence was defined as the appearance of new intrahepatic lesions which was confirmed based on findings of hypervascularity (nodules enhanced in the arterial phase and washout in the late phase) by dynamic CT images, or a new extrahepatic metastasis. Recurrence of intrahepatic HCC was evaluated by an independent image reading committee. RFS was defined as the time from randomization to HCC recurrence or death from any cause, whichever occurred first. For subjects who terminated the study without HCC recurrence or death, RFS was censored at the day of the latest dynamic CT examination.

  Date of randomization to the date of recurrence of HCC (followed every 12 weeks) or death (whichever occurs first)

Secondary Outcomes (2)

• Disease-free Survival

  Date of randomization to the date of recurrence of HCC (followed every 12 weeks), death, or secondary cancer (malignant tumors other than HCC)(whichever occurs first)

• Time to Recurrence

  Date of randomization to the date of recurrence of HCC(followed every 12 weeks)

Study Arms (2)

NIK-333(peretinoin)

EXPERIMENTAL

Drug: NIK-333(peretinoin)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NIK-333(peretinoin) DRUG

600mg (8 x 75mg capsules) orally, twice a day

NIK-333(peretinoin)

Placebo DRUG

Placebo (8 x Placebo capsules) orally, twice a day

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.
• Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
• 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
• Patients with ECOG Performance Status score of 0 to 1
• Patients of the age of 20 years or older at the time of informed consent

You may not qualify if:

• Patients positive for HBs antigen
• Patients showing vascular invasion of HCC on imaging diagnosis
• Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy
• Patients who want to receive antiviral therapy such as concomitant therapy with intaferon during the study period
• Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy
• 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)
• 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
• Patients with a history of total gastrectomy
• Patients with a history of cardiac arrest
• 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (66)

Unknown Facility

Nagoya, Aichi-ken, 466-0065, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-0001, Japan

Location

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Unknown Facility

Matsuyama, Ehime, 790-0826, Japan

Location

Unknown Facility

Iizuka, Fukuoka, 820-0018, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-0011, Japan

Location

Unknown Facility

Ōgaki, Gifu, 503-0864, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 006-8555, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0033, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-8648, Japan

Location

Unknown Facility

Himeji, Hyōgo, 670-0063, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0047, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 213-8587, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 228-8520, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 252-0375, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 232-0024, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 241-0815, Japan

Location

Unknown Facility

Nankoku, Kochi, 783-8505, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, 701-0192, Japan

Location

Unknown Facility

Ikeda, Osaka, 563-8510, Japan

Location

Unknown Facility

Moriguchi, Osaka, 570-8507, Japan

Location

Unknown Facility

Sakai, Osaka, 591-8025, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Unknown Facility

Iruma, Saitama, 350-0495, Japan

Location

Unknown Facility

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Unknown Facility

Shimotsuke, Tochigi, 329-0498, Japan

Location

Unknown Facility

Bunkyo-ku,, Tokyo, 113-8519, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-0021, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8643, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Unknown Facility

Minato-ku, Tokyo, 105-8470, Japan

Location

Unknown Facility

Musashino, Tokyo, 180-8610, Japan

Location

Unknown Facility

Ōta-ku, Tokyo, 143-8541, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 158-8531, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Unknown Facility

Shimonoseki, Yamaguchi, 750-0061, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-8505, Japan

Location

Unknown Facility

Kofu, Yamanashi, 400-8506, Japan

Location

Unknown Facility

Chiba, 260-0856, Japan

Location

Unknown Facility

Fukuoka, 810-8563, Japan

Location

Unknown Facility

Fukuoka, 814-0180, Japan

Location

Unknown Facility

Gifu, 500-8513, Japan

Location

Unknown Facility

Gifu, 501-1194, Japan

Location

Unknown Facility

Hiroshima, 734-8530, Japan

Location

Unknown Facility

Hiroshima, 734-8551, Japan

Location

Unknown Facility

Kagoshima, 890-8520, Japan

Location

Unknown Facility

Kumamoto, 860-0811, Japan

Location

Unknown Facility

Nagasaki, 852-8501, Japan

Location

Unknown Facility

Niigata, 950-1104, Japan

Location

Unknown Facility

Okayama, 700-8558, Japan

Location

Unknown Facility

Osaka, 534-0021, Japan

Location

Unknown Facility

Osaka, 537-8511, Japan

Location

Unknown Facility

Osaka, 540-0006, Japan

Location

Unknown Facility

Osaka, 543-8555, Japan

Location

Unknown Facility

Osaka, 545-8586, Japan

Location

Unknown Facility

Ōita, 879-5593, Japan

Location

Unknown Facility

Saga, 840-8571, Japan

Location

Unknown Facility

Saga, 849-8501, Japan

Location

Unknown Facility

Tokushima, 770-8503, Japan

Location

Unknown Facility

Tokushima, 770-8539, Japan

Location

Unknown Facility

Wakayama, 641-8510, Japan

Location

Results Point of Contact

• Title: Administrator of clinical trial information
• Organization: Pharmaceutical Division, Clinical Administration Dept.

ctrdinfo@kowa.co.jp

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 16, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Locations

JP (66)