Liver Cancer
Conditions
Brief summary
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
Interventions
DRUGARQ197
DRUGPlacebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent form * ≥20 years old * Inoperable HCC which is not eligible for locoregional therapy * Diagnosed as c-Met high in tumor sample * Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 * Child-Pugh Class A * Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, * Negative pregnancy test results * Adequate organ function * Life expectancy of at least 12 weeks
Exclusion criteria
* More than 2 prior systemic chemotherapy. * Prior therapy of c-Met inhibitor (including antibody) * Any systemic therapy within ≤2 weeks prior to the randomization * Locoregional therapy within ≤4 weeks prior to randomization. * Major surgery within ≤4 weeks prior to the randomization * Concurrent cancer within ≤5 years prior to the randomization * History of cardiac diseases * Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0 * Any psychological disorder affecting Informed Consent * Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody * Blood or albumin transfusion within ≤14 days prior to the screening test * Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV) * Symptomatic brain metastases * History of liver transplantation * Inability to swallow oral medications * Confirmed interstitial lung disease * Pleural effusion and/or clinically significant ascites * Pregnancy or breast-feeding * Without consent to effective single or combined contraceptive methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Estimated median of 8-12 weeks in PFS | Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Estimated median of 24 weeks in overall survival | The date of the events was followed every three months after the end of the treatments of the study drug. |
Countries
Japan
Outcome results
None listed