A Study of ARQ 197 in Combination With Erlotinib

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT01069757
Phase
PHASE1
Status
Completed

Conditions

  • Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARQ 197 and Erlotinib — DRUG
    Orally twice daily administration of ARQ 197 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 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
Feb 17, 2010
Start date
Feb 28, 2010
Status verified
Mar 2017
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ARQ 197 and Erlotinib
    ARQ 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. ]

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