Back to resultsStudy of ARQ 197 Monotherapy (ARQ 197-004)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ARQ 197
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Advanced/recurrent gastric cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARQ 197
Arm Description
Outcomes
Primary Outcome Measures
Antitumor effect
Disease control
Secondary Outcome Measures
Antitumor effect
Tumor response
Progression-free survival
Overall survival
Pharmacokinetic profile
Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01152645
Brief Title
Study of ARQ 197 Monotherapy
Acronym
ARQ 197-004
Official Title
Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Advanced/recurrent gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARQ 197
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARQ 197
Intervention Description
Orally twice daily administration of ARQ 197
Primary Outcome Measure Information:
Title
Antitumor effect
Description
Disease control
Time Frame
Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Secondary Outcome Measure Information:
Title
Antitumor effect
Description
Tumor response
Time Frame
Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Title
Progression-free survival
Time Frame
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.
Title
Overall survival
Time Frame
Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Title
Pharmacokinetic profile
Description
Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197
Time Frame
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.
Title
Adverse events
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Nagoya
Country
Japan
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of ARQ 197 Monotherapy
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