Clinical trial NCT01152645: Study of ARQ 197 Monotherapy
Official title: Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Advanced/recurrent gastric cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Antitumor effect
timeFrame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Secondary outcomes:
measure: Antitumor effect
timeFrame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
measure: Progression-free survival
timeFrame: 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.
measure: Overall survival
timeFrame: Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
measure: Pharmacokinetic profile
timeFrame: 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.
measure: Adverse events
timeFrame: 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.
Other outcomes:
Locations:
city: Nagoya
country: Japan
city: Seoul
country: Korea, Republic of
Study officials:
References: