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ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01580735
First received: April 16, 2012
Last updated: August 16, 2015
Last verified: August 2015
  Purpose
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.

Condition Intervention Phase
Non-small-cell Lung Cancer Drug: ARQ 197 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Up to 6 months ]
    To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.


Secondary Outcome Measures:
  • To examine the progression free survival [ Time Frame: 30 months ]
    To examine the progression free survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib

  • To examine the overall survival [ Time Frame: 30 months ]
    To examine the overall survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib

  • To examine the disease control rate [ Time Frame: 30 months ]
    To examine the disease control rate of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib

  • To estimate the safety profile [ Time Frame: 30 months ]
    To estimate the safety profile of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib


Estimated Enrollment: 40
Study Start Date: May 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197 Drug: ARQ 197

ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM)

erlotinib: 150 mg qd


  Eligibility

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

Key Inclusion Criteria:

  • Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
  • Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function

Key Exclusion Criteria:

  • Prior therapy with a c-Met inhibitor.
  • Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
  • Major surgical procedure within 4 weeks prior to randomization
  • Known symptomatic brain metastases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580735

Locations
Japan
Arakawa-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01580735     History of Changes
Other Study ID Numbers: ARQ 197-007
23-4882 ( Registry Identifier: Pharmaceuticals and Medical Devices Agency )
Study First Received: April 16, 2012
Last Updated: August 16, 2015

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
NSCLC
c-MET
EGFR mutation-positive
gefitinib
erlotinib
EGFR-TKI resistance

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

ClinicalTrials.gov processed this record on July 21, 2017