NCT02029157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

December 27, 2013

Last Update Submit

October 6, 2017

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (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 Outcomes (1)

  • Overall survival

    Estimated median of 24 weeks in overall survival

Study Arms (2)

ARQ 197

EXPERIMENTAL

Daily oral dose

Drug: ARQ197

Placebo

PLACEBO COMPARATOR

Daily oral dose

Drug: Placebo

Interventions

ARQ197DRUG
ARQ 197
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Centers in Japan

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 32716114DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Interventions

ARQ 197

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2013

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

JP(1)