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

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Orantinib (TSU-68)

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chiba University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Orantinib

Outcomes

Primary Outcome Measures

Step 1(Phase I) Safety

Step 2(Phase II) Response rate(RR)

Secondary Outcome Measures

Step 1(Phase I) Response rate(RR)

Step 2(Phase II) Safety

Full Information

NCT ID

NCT00784290

First Posted

October 30, 2008

Last Updated

March 22, 2012

Sponsor

Taiho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00784290

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Orantinib

Intervention Type

Drug

Intervention Name(s)

Orantinib (TSU-68)

Intervention Description

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

Primary Outcome Measure Information:

Title

Step 1(Phase I) Safety

Time Frame

During chemotherapy

Title

Step 2(Phase II) Response rate(RR)

Time Frame

Until progression

Secondary Outcome Measure Information:

Title

Step 1(Phase I) Response rate(RR)

Time Frame

Until progression

Title

Step 2(Phase II) Safety

Time Frame

During chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masao Omata, M.D.

Organizational Affiliation

Yamanashi Prefectural Central Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Chiba University Hospital

City

Inohana Chuo-ku Chiba

State/Province

Chiba

ZIP/Postal Code

260-8670

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

21935635

Citation

Enooku K, Tateishi R, Kanai F, Kondo Y, Masuzaki R, Goto T, Shiina S, Yoshida H, Omata M, Koike K. Evaluation of molecular targeted cancer drug by changes in tumor marker doubling times. J Gastroenterol. 2012 Jan;47(1):71-8. doi: 10.1007/s00535-011-0462-2. Epub 2011 Sep 21.

Results Reference

derived

PubMed Identifier

20390419

Citation

Kanai F, Yoshida H, Tateishi R, Sato S, Kawabe T, Obi S, Kondo Y, Taniguchi M, Tagawa K, Ikeda M, Morizane C, Okusaka T, Arioka H, Shiina S, Omata M. A phase I/II trial of the oral antiangiogenic agent TSU-68 in patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2011 Feb;67(2):315-24. doi: 10.1007/s00280-010-1320-2.

Results Reference

derived

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

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