Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
This study is currently recruiting participants.
Verified March 2013 by Kyowa Hakko Kirin Company, Limited
Sponsor:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01656265
First received: July 20, 2012
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Hepatocellular Carcinoma |
Drug: ARQ 197 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma |
Further study details as provided by Kyowa Hakko Kirin Company, Limited:
Primary Outcome Measures:
- Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability [ Time Frame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment. ] [ Designated as safety issue: Yes ]Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
Secondary Outcome Measures:
- Profiles of Pharmacokinetics [ Time Frame: Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29. ] [ Designated as safety issue: No ]maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), apparent clearance (Cl/F), and apparent volume of distribution in the terminal elimination phase (Vz/F).
- Antitumor effects according to RECIST 1.1. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ARQ 197 |
Drug: ARQ 197
Daily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule.
Other Name: Tivantinib
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh classification A at the time of registration
- Adequate bone marrow, liver, and renal functions within 14 days prior to registration
Exclusion Criteria:
- Prior therapy with a c-Met inhibitor (including ARQ 197)
- Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
- Local treatment for malignancy within 4 weeks prior to registration
- Major surgical procedure within 4 weeks prior to registration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656265
Locations
| Japan | |
| Recruiting | |
| Kashiwa-city, Chiba, Japan | |
| Contact: Kyowa Hakko Kirin clinical.info@kyowa-kirin.co.jp | |
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
More Information
No publications provided
| Responsible Party: | Kyowa Hakko Kirin Company, Limited |
| ClinicalTrials.gov Identifier: | NCT01656265 History of Changes |
| Other Study ID Numbers: | ARQ 197-008 |
| Study First Received: | July 20, 2012 |
| Last Updated: | March 22, 2013 |
| 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 16, 2013