A Phase III trial of ARQ 197 in hepatocellular carcinoma (HCC)

Phase 3

• Conditions: hepatocellular carcinoma

• Registration Number: JPRN-jRCT2080222351
• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1) Informed consent form
2) 20 years or older
3) Inoperable HCC which is not eligible for locoregional therapy
4) Diagnosed as c-Met high in tumor sample
5) Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
6) ECOG PS is 0 or 1
7) Child-Pugh Class A
8) Having measurable target lesions which are defined by RECIST version 1.1,
9) Negative pregnancy test results
10) Adequate organ function
11) Life expectancy of at least 12 weeks

Exclusion Criteria

1) More than 2 prior systemic chemotherapy.
2) Prior therapy of c-Met inhibitor (including antibody)
3) Any systemic therapy within 2 weeks prior to the randomization
4) Locoregional therapy within 4 weeks prior to randomization.
5) Major surgery within 4 weeks prior to the randomization
6) Concurrent cancer within 5 years prior to the randomization
7) History of cardiac diseases
8) Active clinically serious infections defined as Grade 3 or higher according to CTCAE 4.0
9) Any psychological disorder affecting Informed Consent
10) Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
11) Blood or albumin transfusion within 14 days prior to the screening test
12) Concurrent interferon therapy against HBV/HCV
13) Symptomatic brain metastases
14) History of liver transplantation
15) Inability to swallow oral medications
16) Confirmed interstitial lung disease
18) Pleural effusion and/or clinically significant ascites
19) Pregnancy or breast-feeding
20) Without consent to effective single or combined contraceptive methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified