We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 46 for:    ARQ 197

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

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.
ClinicalTrials.gov Identifier: NCT01580735
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: ARQ 197 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: ARQ 197 Drug: ARQ 197

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

erlotinib: 150 mg qd




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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): NCT01580735


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

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 )
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 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