A Study of ARQ 197 in Combination With Erlotinib

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

Non-small-cell Lung Cancer

Treatments

Drug: ARQ 197 and Erlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01069757

ARQ 197-003

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntary written informed consent for study participation must be obtained
A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
ECOG PS of 0 or 1
Life expectancy of ≥3 months

Exclusion criteria

Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
Surgery for cancer within 28 days prior to ARQ 197 dose
Active double cancer
Known symptomatic brain metastases
An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
Pregnant or lactating
Subjects who wish to have a child and who would not agree to use contraceptive measures