Status:
COMPLETED
A Study of ARQ 197 in Combination With Erlotinib
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Advanced/Recurrent Non-small-cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
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 CYP2C19 poor metabolizer patients wit...
Eligibility Criteria
Inclusion
- 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
- Poor metabolizers as defined by CYP2C19 genotype
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01251796
Start Date
December 1 2010
End Date
November 1 2012
Last Update
March 15 2017
Active Locations (1)
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1
Shizuoka, Japan