Study of ARQ 197 Monotherapy

Gastric Cancer Clinical Trial

— ARQ 197-004  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152645
• Other study ID #: ARQ 197-004
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2010
• Last updated: March 14, 2017
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• ARQ 197
Orally twice daily administration of ARQ 197

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor effect	Disease control	Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Secondary	Antitumor effect	Tumor response	Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Secondary	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.
Secondary	Overall survival		Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Secondary	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.
Secondary	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.