Phase I study of ARQ 197 in HCC

Phase I study of ARQ 197 in advanced hepatocellular carcinoma

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221860

Enrollment

Registered

2012-07-20

Start date

2012-07-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

advanced HCC

Interventions

investigational material(s) Generic name etc : ARQ 197 INN of investigational material : Tivantinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major 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

Exclusion criteria: Major 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
Safety Dose escalation to evaluate the tolerable dose of ARQ 197, CTCAE ver 4.0	—

Secondary

Measure	Time frame
Pharmacokinetics profiles Antitumor activity Measurement of plasma concentration, RECIST 1.1	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026