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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029157
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 27, 2013
First Posted Date  ICMJE January 7, 2014
Last Update Posted Date October 9, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02029157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE
  • Drug: ARQ197
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ARQ 197
    Daily oral dose
    Intervention: Drug: ARQ197
  • Placebo Comparator: Placebo
    Daily oral dose
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
386
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2014)
160
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02029157
Other Study ID Numbers  ICMJE ARQ 197-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Co., Ltd.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP