A Study of ARQ 197 in Combination With Erlotinib
- Sponsor
- Kyowa Kirin Co., Ltd.
- Study ID
- NCT01251796
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced/Recurrent Non-small-cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ARQ 197 and Erlotinib — DRUGOrally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
Study Details
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.
Key Dates
- First listed
- Dec 2, 2010
- Start date
- Dec 31, 2010
- Status verified
- Mar 2017
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ARQ 197 and ErlotinibARQ 197 and erlotinib hydrochloride
Primary Outcome Measure
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib [ 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. ]