Clinical trial NCT02029157: A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
Official title: A Phase III Randomized Double-blind, Placebo-controlled Trial of ARQ 197 in Subjects With c-MET Diagnostic-high Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Sorafenib Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 386
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Estimated median of 8-12 weeks in PFS
Secondary outcomes:
measure: Overall survival
timeFrame: Estimated median of 24 weeks in overall survival
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Cancer Centers in Japan
Study officials:
References:
citation: Kudo M, Morimoto M, Moriguchi M, Izumi N, Takayama T, Yoshiji H, Hino K, Oikawa T, Chiba T, Motomura K, Kato J, Yasuchika K, Ido A, Sato T, Nakashima D, Ueshima K, Ikeda M, Okusaka T, Tamura K, Furuse J. A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma. Cancer Sci. 2020 Oct;111(10):3759-3769. doi: 10.1111/cas.14582. Epub 2020 Aug 26.