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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.
Details
| Lead sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2010-02 |
| Completion | 2011-09 |
Conditions
- Non-small-cell Lung Cancer
Interventions
- ARQ 197 and Erlotinib
Primary outcomes
- Dose-Limiting Toxicity in the combination of tivantinib and erlotinib — DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Countries
Japan