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

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Orantinib (TSU-68)

• Registration Number: NCT00784290
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-11-02
• Primary Completion: 2010-10
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Orantinib (TSU-68)	Orantinib

Primary Outcome Measures

Name	Time	Method
Step 1(Phase I) Safety	During chemotherapy
Step 2(Phase II) Response rate(RR)	Until progression

Secondary Outcome Measures

Name	Time	Method
Step 1(Phase I) Response rate(RR)	Until progression
Step 2(Phase II) Safety	During chemotherapy

Trial Locations

Locations (1)

Chiba University Hospital; 🇯🇵 Inohana Chuo-ku Chiba, Chiba, Japan