Study of ARQ 197 Monotherapy

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: ARQ 197

• Registration Number: NCT01152645
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-27
• Study First Posted: 2010-06-29
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ 197	ARQ 197	-

Primary Outcome Measures

Name	Time	Method
Antitumor effect	Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.	Disease control

Secondary Outcome Measures

Name	Time	Method
Overall survival	Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
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.
Pharmacokinetic profile	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.	Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197
Antitumor effect	Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.	Tumor response
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.