Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

Phase 1

Completed

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: ARQ 197

• Registration Number: NCT01656265
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ 197	ARQ 197	-

Primary Outcome Measures

Name	Time	Method
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability	DLT observation period will be the first 28 days after the start of ARQ 197 treatment.	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

Name	Time	Method
Antitumor effects according to RECIST 1.1.	Every 6 weeks
Profiles of Pharmacokinetics	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.	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).