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

Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580735
• Other study ID #: ARQ 197-007
• Secondary ID: 23-4882
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2012
• Last updated: August 16, 2015
• Start date: May 2012
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• ARQ 197
ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM) erlotinib: 150 mg qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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.	Up to 6 months	No
Secondary	To examine the progression free survival	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	30 months	No
Secondary	To examine the overall survival	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	30 months	No
Secondary	To examine the disease control rate	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	30 months	No
Secondary	To estimate the safety profile	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	30 months	Yes