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A Study of ARQ 197 in Combination With Erlotinib | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT01069757

A Study of ARQ 197 in Combination With Erlotinib

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-...

Lead sponsor: Kyowa Kirin Co., Ltd.•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Kyowa Kirin Co., Ltd.

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 15, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment16

Start dateFeb 2010

Last updatedMar 15, 2017

Condition

Non-small-cell Lung Cancer

Locations shown

Osaka

Shizuoka

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2017Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions