Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Orantinib (TSU-68) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma |
- Step 1(Phase I) Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]
- Step 2(Phase II) Response rate(RR) [ Time Frame: Until progression ] [ Designated as safety issue: No ]
- Step 1(Phase I) Response rate(RR) [ Time Frame: Until progression ] [ Designated as safety issue: No ]
- Step 2(Phase II) Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | September 2003 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Orantinib
|
Drug: Orantinib (TSU-68)
200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops
|
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| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Japan | |
| Chiba University Hospital | |
| Inohana Chuo-ku Chiba, Chiba, Japan, 260-8670 | |
| Study Chair: | Masao Omata, M.D. | Yamanashi Prefectural Central Hospital |
More Information
No publications provided by Taiho Pharmaceutical Co., Ltd.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Taiho Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00784290 History of Changes |
| Other Study ID Numbers: | Taiho132070 |
| Study First Received: | October 30, 2008 |
| Last Updated: | March 22, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013