A Study of ARQ 197 in Combination With Erlotinib

• Status: Completed
• Trial end date: 2012-11-01
• 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 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.

• 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

• Poor metabolizers as defined by CYP2C19 genotype

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