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

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. Identifier: NCT01377376
Recruitment Status : Terminated
First Posted : June 21, 2011
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: ARQ 197 and Erlotinib Drug: Placebo and Erlotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2011
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Progression free survival
  2. Objective response rate
    Each assessment will be determined based on RECIST criteria version 1.1 by investigator

  3. Number of patients with adverse events

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.

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

Inclusion Criteria

  1. Male or female at least 20 years of age with life expectancy ≥ 3 months
  2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay
  3. Evaluable disease according to RECIST, Version 1.1
  4. 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
  5. ECOG performance status of 0 or 1
  6. Demonstrate adequate bone marrow, liver, and renal functions, defined as:

    • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL.

  7. Voluntary written informed consent form before performance of any study-specific procedures or tests

Exclusion Criteria

  1. Prior therapy with an EGFR inhibitor and/or tivantinib
  2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization
  3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization
  4. Major surgical procedure within 4 weeks prior to randomization
  5. History of cardiac disease
  6. Known symptomatic brain metastases
  7. Need to breastfeed a child during or within 12 weeks of completing the study
  8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib
  9. History of malignancy other than NSCLC
  10. Known infection with HIV, active HBV or HCV
  11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases
  12. Psychiatric disease that could affect the informed consent process
  13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective
  14. Positive serum or urine pregnancy test in female subjects of childbearing potential
  15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation

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 identifier (NCT number): NCT01377376

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Osaka, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kyowa Kirin Co., Ltd. Identifier: NCT01377376    
Other Study ID Numbers: ARQ197-006
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action