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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01580735
First received: April 16, 2012
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Estimated Study Completion Date: November 2014
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580735

Locations
Japan
Arakawa-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01580735     History of Changes
Other Study ID Numbers: ARQ 197-007, 23-4882
Study First Received: April 16, 2012
Last Updated: March 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
NSCLC
c-MET
EGFR mutation-positive
 gefitinib
erlotinib
EGFR-TKI resistance

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

ClinicalTrials.gov processed this record on June 17, 2013