Study Results
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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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2010-02-28
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
ARQ 197 and Erlotinib
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Osaka, , Japan
Shizuoka, , Japan
Countries
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Other Identifiers
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ARQ 197-003
Identifier Type: -
Identifier Source: org_study_id
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