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Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

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. Identifier: NCT00784290
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Orantinib (TSU-68) Phase 1 Phase 2

Detailed Description:
As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is also expected to be effective against HCC. However, because most HCC patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
Study Start Date : September 2003
Actual Primary Completion Date : October 2010
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: 1
Drug: Orantinib (TSU-68)
200 or 400 mg bid day 1~day 28 cycle until progression or unacceptable toxicity develops

Primary Outcome Measures :
  1. Step 1(Phase I) Safety [ Time Frame: During chemotherapy ]
  2. Step 2(Phase II) Response rate(RR) [ Time Frame: Until progression ]

Secondary Outcome Measures :
  1. Step 1(Phase I) Response rate(RR) [ Time Frame: Until progression ]
  2. Step 2(Phase II) Safety [ Time Frame: During chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 20-74
  • PS 0-2
  • Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy
  • Chid-Pugh A or B
  • At least one measurable lesion by RECIST criteria

Exclusion Criteria:

  • Large amount of pleural effusion or ascites
  • Esophageal varices
  • Simultaneously active double cancer

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 identifier (NCT number): NCT00784290

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Chiba University Hospital
Inohana Chuo-ku Chiba, Chiba, Japan, 260-8670
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
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Study Chair: Masao Omata, M.D. Yamanashi Prefectural Central Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00784290     History of Changes
Other Study ID Numbers: Taiho132070
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Enzyme Inhibitors
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Molecular Mechanisms of Pharmacological Action