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A Phase 1 Study of ARQ 197 in Patients With Solid Tumors

NCT ID: NCT00609921

Last Updated: 2012-09-07

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

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Detailed Description

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Conditions

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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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1

ARQ197

Group Type ACTIVE_COMPARATOR

ARQ197

Intervention Type DRUG

treatment

Interventions

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ARQ197

treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists.
* Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Patients with adequate organ function

Exclusion Criteria

* Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197
* Known symptomatic brain metastases
* Pregnant or breastfeeding
* Uncontrolled intercurrent illness
Minimum Eligible Age

20 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

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Countries

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Japan

Other Identifiers

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ARQ 197-0701

Identifier Type: -

Identifier Source: org_study_id