A Study of ARQ 197 in Combination With Erlotinib

A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer

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.

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