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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Enrollment
9
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
Unnamed facility
Shizuoka, Japan
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Time frame: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Pharmacokinetic profile of ARQ 197
Summary statistics of plasma concentration and pharmacokinetic parameters
Time frame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Pharmacokinetic profile of Erlotinib
Summary statistics of plasma concentration and pharmacokinetic parameters
Time frame: At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Antitumor activity
Response rate
Time frame: Baseline, and then every 6 week of imaging until discontinuation criteria met
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