Overview

A Study of ARQ 197 in Combination With Erlotinib

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited
Kyowa Kirin Co., Ltd.
Treatments:
Erlotinib Hydrochloride
Criteria
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