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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465464
First Posted: November 4, 2011
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

Enrollment: 888
Study Start Date: December 2010
Study Completion Date: November 2014
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01465464     History of Changes
Other Study ID Numbers: Taiho132150
First Submitted: November 1, 2011
First Posted: November 4, 2011
Last Update Posted: February 6, 2017
Last Verified: February 2017

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