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Clinical Trials/NCT01656265
NCT01656265CompletedPhase 1

Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

Kyowa Kirin Co., Ltd.0 sites24 target enrollmentStarted: July 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
24
Primary Endpoint
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ARQ 197

Experimental

Intervention: ARQ 197 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Antitumor effects according to RECIST 1.1.(Every 6 weeks)
  • 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.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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Study of ARQ 197 in Hepatocellular... | Clinical Trial