Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656265
• Other study ID #: ARQ 197-008
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2012
• Last updated: February 28, 2017
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• ARQ 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Profiles of Pharmacokinetics	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).	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.
Secondary	Antitumor effects according to RECIST 1.1.		Every 6 weeks