Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.

Key facts

Study ID

NCT01755767

Run by

Daiichi Sankyo

People needed

383

Starts

2012-12-27

Expected to finish

2017-07-31

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed HCC that is inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), and not eligible for local therapy
• MET Diagnostic-High tissue reported by the central authorized laboratory using archival or recent biopsy tumor samples
• Received at least 4 weeks of one prior sorafenib containing systemic therapy and then experienced documented radiographic disease progression; or inability to tolerate prior therapy received for at least a minimum period of time.
• Discontinued prior systemic treatment or any investigational drug for at least 2 weeks (14 days) or for at least 3 weeks for IV anti-cancer drugs, prior to the study randomization
• Local or loco-regional therapy (i.e., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >= 4 weeks prior to randomization
• Measurable disease as defined by the RECIST v1.1.

You may not qualify if…

• More than 1 prior systemic regimen (prior MET inhibitors/antibodies are not allowed; experimental systemic therapy for inoperable HCC given before or after sorafenib counts as separate regimen and is not allowed)
• Child-Pugh B-C cirrhotic status based on clinical findings and laboratory results
• Previous or concurrent cancer that is distinct from HCC in primary site or histology, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors. Any cancer curatively treated more than 3 years prior to enrollment is permitted.
• History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as greater than or equal to Grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring more than 6 months prior to study entry is permitted)
• Active clinically serious infections defined as >= Grade 3 according to NCI CTCAE
• Any medical, psychological, or social conditions, particularly if unstable, including substance abuse, that may, in the opinion of the Investigator, interfere with the subject's safety or participation in the study, protocol compliance, or evaluation of the study results
• Known human immunodeficiency virus (HIV) infection
• Blood or albumin transfusion within 5 days prior to the blood draw being used to confirm eligibility
• Concomitant interferon therapy or therapies for active Hepatitis C virus (HCV) infection
• Pregnancy or breast-feeding
• History of liver transplant
• Inability to swallow oral medications
• Clinically significant gastrointestinal bleeding occurring <= 4 weeks prior to randomization
• Pleural effusion or clinically evident (visible or palpable) ascites

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Westwood, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Study site — Buenos Aires, Buenos Aires F.D., Argentina
• Study site — Pilar, Argentina
• Study site — Camperdown, New South Wales, Australia
• Study site — Heidelberg, Victoria, Australia
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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