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A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib (ATTENTION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01377376
First received: June 17, 2011
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.


Condition Intervention Phase
Non-small-cell Lung Cancer
 Drug: ARQ 197 and Erlotinib
Drug: Placebo and Erlotinib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor

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:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Designated as safety issue: No ]
  • Objective response rate [ Designated as safety issue: No ]
    Each assessment will be determined based on RECIST criteria version 1.1 by investigator

  • Number of patients with adverse events [ Designated as safety issue: Yes ]

Study Start Date: July 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197
ARQ 197 and Erlotinib
 Drug: ARQ 197 and Erlotinib
Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
Placebo Comparator: Placebo
Placebo and Erlotinib
 Drug: Placebo and Erlotinib
Oral twice daily administration of placebo and oral once daily administration of erlotinib

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type EGFR.
  • Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
  • Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Prior therapy with an EGFR inhibitor and/or c-Met inhibitor.
  • Any systemic anti-tumor treatment for NSCLC within 4 weeks 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: NCT01377376

Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01377376     History of Changes
Other Study ID Numbers: ARQ197-006
Study First Received: June 17, 2011
Last Updated: March 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration

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 May 23, 2013