Skip to main content
OpenTrials
Completed

NCT Number: NCT01251796

A Study of ARQ 197 in Combination With Erlotinib

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced/Recurrent Non-small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shizuoka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARQ 197 and Erlotinib

Drug

Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride

Primary outcomes

  1. 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.

    Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.

Secondary outcomes

  1. Pharmacokinetic profile of ARQ 197

    Time frame: 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

  2. Pharmacokinetic profile of Erlotinib

    Time frame: 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

  3. Antitumor activity

    Time frame: Baseline, and then every 6 week of imaging until discontinuation criteria met

    Response rate

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2010
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.