Study of ARQ 197 Monotherapy

NCT01152645 | Completed Phase 2

• 1 other identifier: ARQ 197-004
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

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.

Conditions

Gastric Cancer

Keywords

Advanced/recurrent gastric cancer

Outcome Measures

Primary Outcomes (1)

• Antitumor effect

  Disease control

  Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.

Secondary Outcomes (5)

• Antitumor effect

  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 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.

Study Arms (1)

ARQ 197

EXPERIMENTAL

Drug: ARQ 197

Interventions

ARQ 197 DRUG

Orally twice daily administration of ARQ 197

ARQ 197

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ARQ 197

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

KR (1); JP (1)