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

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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 Hakko Kirin Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: ARQ197 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: ARQ 197
Daily oral dose
Drug: ARQ197
Placebo Comparator: Placebo
Daily oral dose
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029157


Locations
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Japan
Cancer Centers in Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT02029157     History of Changes
Other Study ID Numbers: ARQ 197-009
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases