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

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ClinicalTrials.gov Identifier: NCT01465464
Recruitment Status : Terminated
First Posted : November 4, 2011
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Orantinib (TSU-68) Drug: Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 888 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Overall survival(OS)

Secondary Outcome Measures :
  1. Safety profile


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01465464     History of Changes
Other Study ID Numbers: Taiho132150
First Posted: November 4, 2011    Key Record Dates
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