A Study of ARQ 197 in Combination With Erlotinib

Phase 1

Completed

• Conditions: Advanced/Recurrent Non-small-cell Lung Cancer
• Interventions: Drug: ARQ 197 and Erlotinib

• Registration Number: NCT01251796
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-29
• Study Start: 2010-12
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ 197 and Erlotinib	ARQ 197 and Erlotinib	ARQ 197 and erlotinib hydrochloride

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib	DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.	Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.

Secondary Outcome Measures

Name	Time	Method
Antitumor activity	Baseline, and then every 6 week of imaging until discontinuation criteria met	Response rate
Pharmacokinetic profile of Erlotinib	At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment	Summary statistics of plasma concentration and pharmacokinetic parameters
Pharmacokinetic profile of ARQ 197	Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment	Summary statistics of plasma concentration and pharmacokinetic parameters