A Phase 1 interventional study of ARQ 197 and Erlotinib in Non-small-cell Lung Cancer, sponsored by Kyowa Kirin Co., Ltd.. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-15.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
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ARQ 197 and erlotinib hydrochloride
Drug: ARQ 197 and Erlotinib
Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.