Study of ARQ 197 Monotherapy

Study Overview
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Brief Summary
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A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.

Official Title
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Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: ARQ 197


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese or Korean with voluntary written informed consent for study participation A histologically or cytologically confirmed advanced/recurrent gastric cancer One or two prior chemotherapy regimens for advanced/recurrent gastric cancer At least one measurable lesion ECOG performance status of 0 or 1 Life expectancy ≥3 months Exclusion Criteria: Surgery for cancer within 4 weeks prior to the first dose of ARQ 197 Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197 Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197 Positive for HIV antibody Known symptomatic brain metastasis Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders Uncontrolled concomitant disease Patients who wish to have a child and who would not agree to use contraceptive measures Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARQ 197<br> | Drug: ARQ 197<br>* Orally twice daily administration of ARQ 197<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect | Disease control | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect | Tumor response | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. | 
| Progression-free survival |  | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey. | 
| Overall survival |  | Survival was confirmed by biweekly inquiry during the study, and by follow up survey. | 
| Pharmacokinetic profile | Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197 | Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29. | 
| Adverse events |  | Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced/recurrent gastric cancer