Study of ARQ 197 Monotherapy | NCT01152645

Studies
Study of ARQ 197 Monotherapy

NCT01152645

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Mar 15, 2017Actual

Enrollment

31Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

ARQ 197

Countries

Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 25, 2010

First Submission Date that Met QC Criteria

Jun 27, 2010

First Posted Date

Jun 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2017

Last Update Posted Date

Mar 15, 2017Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
ARQ 197	Experimental		Drug: ARQ 197

Name	Type	Description	Arm Group Labels	Other Names
ARQ 197	Drug	Orally twice daily administration of ARQ 197	ARQ 197

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Antitumor effect	Tumor response	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Nagoya			Japan