Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01656265

Enrollment

Registered

2012-08-02

Start date

2012-07-31

Completion date

2014-03-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Brief summary

The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.

Interventions

DRUGARQ 197

Daily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Child-Pugh classification A at the time of registration * Adequate bone marrow, liver, and renal functions within 14 days prior to registration

Exclusion criteria

* Prior therapy with a c-Met inhibitor (including ARQ 197) * Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks * Local treatment for malignancy within 4 weeks prior to registration * Major surgical procedure within 4 weeks prior to registration

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability	DLT observation period will be the first 28 days after the start of ARQ 197 treatment.	Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.

Secondary

Measure	Time frame	Description
Profiles of Pharmacokinetics	Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.	maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), apparent clearance (Cl/F), and apparent volume of distribution in the terminal elimination phase (Vz/F).
Antitumor effects according to RECIST 1.1.	Every 6 weeks	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026