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

NCT ID: NCT02029157

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARQ 197

Daily oral dose

Group Type EXPERIMENTAL

ARQ197

Intervention Type DRUG

Placebo

Daily oral dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ARQ197

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Centers in Japan

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 32716114 (View on PubMed)

Other Identifiers

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ARQ 197-009

Identifier Type: -

Identifier Source: org_study_id