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Completed

NCT Number: NCT00784290

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

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).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chiba University Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orantinib (TSU-68)

Drug

200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops

Primary outcomes

  1. Step 1(Phase I) Safety

    Time frame: During chemotherapy

  2. Step 2(Phase II) Response rate(RR)

    Time frame: Until progression

Secondary outcomes

  1. Step 1(Phase I) Response rate(RR)

    Time frame: Until progression

  2. Step 2(Phase II) Safety

    Time frame: During chemotherapy

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2012
First posted
Nov 3, 2008
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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