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

NCT01377376 | Terminated Phase 3

• 1 other identifier: ARQ197-006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (3)

• Progression free survival

• Objective response rate

• Number of patients with adverse events

Study Arms (2)

ARQ 197

EXPERIMENTAL

ARQ 197 and Erlotinib

Drug: ARQ 197 and Erlotinib

Placebo

PLACEBO COMPARATOR

Placebo and Erlotinib

Drug: Placebo and Erlotinib

Interventions

ARQ 197 and Erlotinib DRUG

Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib

ARQ 197

Placebo and Erlotinib DRUG

Oral twice daily administration of placebo and oral once daily administration of erlotinib

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 20 years of age with life expectancy ≥ 3 months
• 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
• Evaluable disease according to RECIST, 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
• ECOG performance status of 0 or 1
• 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.
• Voluntary written informed consent form before performance of any study-specific procedures or tests

You may not qualify if:

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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

Related Publications (1)

• Yoshioka H, Azuma K, Yamamoto N, Takahashi T, Nishio M, Katakami N, Ahn MJ, Hirashima T, Maemondo M, Kim SW, Kurosaki M, Akinaga S, Park K, Tsai CM, Tamura T, Mitsudomi T, Nakagawa K. A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated stage IIIB/IV nonsquamous nonsmall-cell lung cancer harboring wild-type epidermal growth factor receptor (ATTENTION study). Ann Oncol. 2015 Oct;26(10):2066-72. doi: 10.1093/annonc/mdv288. Epub 2015 Jul 7.

  PMID: 26153496 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ARQ 197; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2015
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

JP (1)