Clinical trial NCT00784290: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Step 1(Phase I) Safety
timeFrame: During chemotherapy
measure: Step 2(Phase II) Response rate(RR)
timeFrame: Until progression
Secondary outcomes:
measure: Step 1(Phase I) Response rate(RR)
timeFrame: Until progression
measure: Step 2(Phase II) Safety
timeFrame: During chemotherapy
Other outcomes:
Locations:
city: Inohana Chuo-ku Chiba
country: Japan
facility: Chiba University Hospital
state: Chiba
Study officials:
affiliation: Yamanashi Prefectural Central Hospital
name: Masao Omata, M.D.
role: STUDY_CHAIR
References:
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.
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.