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Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

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.
 
ClinicalTrials.gov Identifier: NCT02400788
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yakult Honsha Co., LTD

Study Description
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Brief Summary:
The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Resminostat Drug: Sorafenib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
Study Start Date : April 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Resminostat + Sorafenib
oral administration
 Drug: Resminostat
Drug: Sorafenib
Active Comparator: Sorafenib
oral administration
 Drug: Sorafenib


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability [ Time Frame: 6 months ]
  2. Phase 2 : Time To Progression (TTP) [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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

Main Inclusion Criteria:

  • Patients with advanced or metastatic hepatocellular carcinoma
  • Patients with ECOG PS of 0-1
  • Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications

Main Exclusion Criteria:

  • Patients with a history of treatment with HDAC inhibitors
  • Pregnant women and lactating mothers
  • Patients with brain metastases or suspected brain metastases based on the clinical symptoms
Contacts and Locations
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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): NCT02400788


Locations
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Japan
Chiba, Japan
Ishikawa, Japan
Kanagawa, Japan
Kochi, Japan
Kyoto, Japan
Osaka, Japan
Saga, Japan
Shizuoka, Japan
Tokyo, Japan
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Yakult Honsha Co., LTD
More Information
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Responsible Party: Yakult Honsha Co., LTD
ClinicalTrials.gov Identifier: NCT02400788    
Other Study ID Numbers: YHI-1001-HCC-02
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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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
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action