Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

ARQ197

Placebo

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.

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

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

Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population.

The date of the events was followed every three months after the end of the treatments of the study drug.

Kyowa Kirin Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.

Giulia Pasello, MD

This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.

TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage

PFS will be assessed From the date of enrollment to the date of first documented disease progression or to the date of death from any cause or to the date of a new anti-cancer therapy, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.

The survival status will be assessed every 12 weeks (±14 days) until 48 months. Patients alive at the time of analysis will be censored at the date of last assessment.

The DCR will be defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) at enrollment until the final visit

Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.

The instruments used for assessing the quality of life are the EORTC QLQ-C30 and QLQ-LC13 questionnaires. Quality of Life will be assessed from the date of enrollment until the end of treatment visit, that is anticipated after maximum 48 months.

Istituto Oncologico Veneto IRCCS

Symptoms and General Pathology

Recurrence

Study Director

This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)	NCT02029157	Liver Cancer	ARQ197 Placebo	20 Years -	Kyowa Kirin Co., Ltd.
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)	NCT02608411	Carcinoma, Smal...	ARQ197	18 Years -	Istituto Oncologico Veneto IRCCS
A Phase 1 Study of ARQ 197 in Patients With Solid Tumors	NCT00609921	Cancer	ARQ197	20 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for arq197

Every month we try and update this database with for arq197 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for arq197

Every month we try and update this database with for arq197 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for arq197 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.