Back to resultsStudy of ARQ 197 in Hepatocellular Carcinoma (HCC)
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ARQ 197
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARQ 197
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01656265
Brief Title
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
Official Title
Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARQ 197
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARQ 197
Other Intervention Name(s)
Tivantinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Description
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.
Time Frame
DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Secondary Outcome Measure Information:
Title
Profiles of Pharmacokinetics
Description
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).
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.
Title
Antitumor effects according to RECIST 1.1.
Time Frame
Every 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Kashiwa-city
State/Province
Chiba
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
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