A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
Conditions
Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: ARQ197 Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Cancer Centers in Japan
Tokyo, Japan
Status: Recruiting
Contact: KYOWA HAKKO KIRIN - clinical.info@kyowa-kirin.co.jp
Start Date
January 2014
Completion Date
December 2016
Sponsors
Kyowa Hakko Kirin Company, Limited
Source
Kyowa Hakko Kirin Company, Limited
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page