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NCT Number: NCT01069757

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 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.

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Key information

Conditions

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

Osaka, Japan

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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

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 ARQ 197 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. Plasma concentration and pharmacokinetic parameters of ARQ 197 and Erlotinib

    Time frame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment

    Plasma concentration of tivantinib was measured on both Day 1 and the first day of the combination. Plasma concentration of erlotinib was also measured on the first day of the combination.

  2. Antitumor activity

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

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 Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 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.

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