Study of ARQ 197 Monotherapy

NCT ID: NCT01152645

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARQ 197

Group Type EXPERIMENTAL

ARQ 197

Intervention Type DRUG

Orally twice daily administration of ARQ 197

Interventions

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ARQ 197

Orally twice daily administration of ARQ 197

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nagoya, , Japan

Site Status

Seoul, , South Korea

Site Status

Countries

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Japan South Korea

Other Identifiers

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ARQ 197-004

Identifier Type: -

Identifier Source: org_study_id

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