Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

NCT01656265 | Completed Phase 1

• 1 other identifier: ARQ 197-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability

  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.

  DLT observation period will be the first 28 days after the start of ARQ 197 treatment.

Secondary Outcomes (2)

• 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.

• Antitumor effects according to RECIST 1.1.

  Every 6 weeks

Study Arms (1)

ARQ 197

EXPERIMENTAL

Drug: ARQ 197

Interventions

ARQ 197 DRUG

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.

Also known as: Tivantinib

ARQ 197

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kashiwa, Chiba, Japan

Location

MeSH Terms

Interventions

ARQ 197

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

JP (1)