Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)
This study is currently recruiting participants.
Verified March 2013 by Taiho Pharmaceutical Co., Ltd.
Sponsor:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01465464
First received: November 1, 2011
Last updated: March 3, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to compare the overall survival (OS) for Orantinib in combination with transcatheter arterial chemoembolization (TACE) versus placebo in combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Orantinib (TSU-68) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma |
Further study details as provided by Taiho Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Overall survival(OS)
Secondary Outcome Measures:
- Safety profile
| Estimated Enrollment: | 880 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Orantinib |
Drug: Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
|
| Placebo Comparator: Placebo |
Drug: Placebo
1 tablet was administered orally twice per day after meals, morning and evening.
|
Detailed Description:
This is a randomized, multi-center, double-blind, placebo-controlled phase III trial of Orantinib administered in combination with TACE in patients with unresectable HCC.
Patients will be randomly assigned (1:1) to receive TACE given in combination with either Orantinib (200 mg orally, twice per day) or placebo.
ORIENTAL:ORantinib InvEstigatioN on TAce combination triaL.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be diagnosed as HCC.
- Patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Patients are able to receive oral medication.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465464
Contacts
| Contact: Taiho Pharmaceutical Co., Ltd. |
Locations
| Japan | |
| Local Institution | Recruiting |
| Osaka-sayama, Osaka, Japan, 589-8511 | |
| Contact: site 03 +81-72-366-0221 | |
| Local Institution | Recruiting |
| Chuo-ku, Tokyo, Japan, 104-0045 | |
| Contact: site 02 +81-3-3542-2511 | |
| Local Institution | Recruiting |
| Chiba, Japan, 260-8677 | |
| Contact: site 01 +81-43-222-7171 | |
| Korea, Republic of | |
| Local Institution | Recruiting |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
| Contact: site 05 +82-31-920-0741 | |
| Local Institution | Recruiting |
| JongNo-Gu, Seoul, Korea, Republic of, 110-744 | |
| Contact: site 04 +82-11-9575-3178 | |
| Taiwan | |
| Local Institution | Recruiting |
| Zhongzheng Dist., Taipei, Taiwan, 100 | |
| Contact: site 06 886-932-334693 | |
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
| Study Director: | Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Taiho Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01465464 History of Changes |
| Other Study ID Numbers: | Taiho132150 |
| Study First Received: | November 1, 2011 |
| Last Updated: | March 3, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 19, 2013