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

Last updated: March 22, 2012
Sponsor: Taiho Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

1/2

Condition

Liver Disease

Cancer/tumors

Carcinoma

Treatment

N/A

Clinical Study ID

NCT00784290
Taiho132070
  • Ages 20-74
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Large amount of pleural effusion or ascites

  • Esophageal varices

  • Simultaneously active double cancer

Study Design

Total Participants: 35
Study Start date:
September 01, 2003
Estimated Completion Date:
March 31, 2012

Study 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.

Connect with a study center

  • Chiba University Hospital

    181 Inohana Chuo-ku Chiba, Chiba 260-8670
    Japan

    Site Not Available

  • Chiba University Hospital

    Inohana Chuo-ku Chiba, Chiba 260-8670
    Japan

    Site Not Available

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