Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01465464
First received: November 1, 2011
Last updated: February 18, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


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
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: NCT01465464

Locations
Japan
Local Institution
Osaka-sayama, Osaka, Japan, 589-8511
Local Institution
Chuo-ku, Tokyo, Japan, 104-0045
Local Institution
Chiba, Japan, 260-8677
Korea, Republic of
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Local Institution
JongNo-Gu, Seoul, Korea, Republic of, 110-744
Taiwan
Local Institution
Zhongzheng Dist., Taipei, Taiwan, 100
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: February 18, 2014
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
Orantinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014