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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784290
• Other study ID #: Taiho132070
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 30, 2008
• Last updated: March 22, 2012
• Start date: September 2003
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Orantinib (TSU-68)
200 or 400 mg bid day 1~day 28 cycle until progression or unacceptable toxicity develops

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Inohana Chuo-ku Chiba	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step 1(Phase I) Safety		During chemotherapy	Yes
Primary	Step 2(Phase II) Response rate(RR)		Until progression	No
Secondary	Step 1(Phase I) Response rate(RR)		Until progression	No
Secondary	Step 2(Phase II) Safety		During chemotherapy	Yes