A Study of ARQ 197 in Combination With Erlotinib

NCT ID: NCT01069757

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

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.

Detailed Description

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Conditions

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Non-small-cell Lung 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 and Erlotinib

ARQ 197 and erlotinib hydrochloride

Group Type EXPERIMENTAL

ARQ 197 and Erlotinib

Intervention Type DRUG

Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride

Interventions

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ARQ 197 and Erlotinib

Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Voluntary written informed consent for study participation must be obtained
* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
* ECOG PS of 0 or 1
* Life expectancy of ≥3 months

Exclusion Criteria

* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
* Surgery for cancer within 28 days prior to ARQ 197 dose
* Active double cancer
* Known symptomatic brain metastases
* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
* Pregnant or lactating
* Subjects who wish to have a child and who would not agree to use contraceptive measures
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

Locations

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Osaka, , Japan

Site Status

Shizuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ARQ 197-003

Identifier Type: -

Identifier Source: org_study_id

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