A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC) (JET-HCC)

October 6, 2017 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

386

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Cancer Centers in Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Daily oral dose
Drug: Placebo
Experimental: ARQ 197
Daily oral dose
Drug: ARQ197

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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.
Estimated median of 8-12 weeks in PFS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
Estimated median of 24 weeks in overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARQ 197-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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