A Study of ARQ 197 in Combination With Erlotinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069757
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Kyowa Hakko 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 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.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: ARQ 197 and Erlotinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
Drug: ARQ 197 and Erlotinib
Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01069757

Osaka, Japan
Shizuoka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01069757     History of Changes
Other Study ID Numbers: ARQ 197-003
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Advanced/recurrent non-small-cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action