Phase I/II Study of TSU-68 for Advanced Hepatocellular Ca... | NCT00784290

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

NCT00784290

Sponsor

Taiho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 26, 2012Estimated

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Orantinib (TSU-68)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Oct 2010Actual

Completion Date

Mar 2012Actual

First Submitted Date

Oct 30, 2008

First Submission Date that Met QC Criteria

Oct 30, 2008

First Posted Date

Nov 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Orantinib	Drug: Orantinib (TSU-68)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orantinib (TSU-68)	Drug	200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Step 1(Phase I) Safety		During chemotherapy
Step 2(Phase II) Response rate(RR)		Until progression

Secondary Outcomes

Measure	Description	Time Frame
Step 1(Phase I) Response rate(RR)		Until progression
Step 2(Phase II) Safety		During chemotherapy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masao Omata, M.D.	Yamanashi Prefectural Central Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiba University Hospital		Inohana Chuo-ku Chiba	Chiba	260-8670	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21935635	Derived	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.
20390419	Derived	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.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type