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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride
Unnamed facility
Osaka, Japan
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.
Plasma concentration and pharmacokinetic parameters of ARQ 197 and Erlotinib
Plasma concentration of tivantinib was measured on both Day 1 and the first day of the combination. Plasma concentration of erlotinib was also measured on the first day of the combination.
Time frame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Antitumor activity
Time frame: Baseline, and then every 6 week of imaging until discontinuation criteria met
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