Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
1 other identifier
interventional
35
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started Sep 2003
Longer than P75 for phase_1 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 26, 2012
March 1, 2012
7.1 years
October 30, 2008
March 22, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Step 1(Phase I) Safety
During chemotherapy
Step 2(Phase II) Response rate(RR)
Until progression
Secondary Outcomes (2)
Step 1(Phase I) Response rate(RR)
Until progression
Step 2(Phase II) Safety
During chemotherapy
Study Arms (1)
1
EXPERIMENTALOrantinib
Interventions
200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Large amount of pleural effusion or ascites
- Esophageal varices
- Simultaneously active double cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chiba University Hospital
Inohana Chuo-ku Chiba, Chiba, 260-8670, Japan
Related Publications (2)
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.
PMID: 21935635DERIVEDKanai 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.
PMID: 20390419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Masao Omata, M.D.
Yamanashi Prefectural Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2008
First Posted
November 3, 2008
Study Start
September 1, 2003
Primary Completion
October 1, 2010
Study Completion
March 1, 2012
Last Updated
March 26, 2012
Record last verified: 2012-03