Hepatocellular Carcinoma
Conditions
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.
Interventions
200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step 1(Phase I) Safety | During chemotherapy |
| Step 2(Phase II) Response rate(RR) | Until progression |
Secondary
| Measure | Time frame |
|---|---|
| Step 1(Phase I) Response rate(RR) | Until progression |
| Step 2(Phase II) Safety | During chemotherapy |
Countries
Japan
Outcome results
None listed