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Trial record 6 of 46 for:    ARQ 197

A Study of ARQ 197 in Combination With Erlotinib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251796
First Posted: December 2, 2010
Last Update Posted: March 15, 2017
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.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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.

Condition Intervention Phase
Advanced/Recurrent Non-small-cell Lung Cancer Drug: ARQ 197 and Erlotinib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • Antitumor activity [ Time Frame: Baseline, and then every 6 week of imaging until discontinuation criteria met ]
    Response rate


Enrollment: 9
Actual Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
Drug: ARQ 197 and Erlotinib
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01251796


Locations
Japan
Shizuoka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01251796     History of Changes
Other Study ID Numbers: ARQ 197-005
First Submitted: November 29, 2010
First Posted: December 2, 2010
Last Update Posted: March 15, 2017
Last Verified: March 2017

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