ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
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
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 18, 2015
August 1, 2015
2.9 years
April 16, 2012
August 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
To examine the progression free survival
30 months
To examine the overall survival
30 months
To examine the disease control rate
30 months
To estimate the safety profile
30 months
Study Arms (1)
ARQ 197
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Arakawa-ku, Tokyo, Japan
Related Publications (1)
Azuma K, Hirashima T, Yamamoto N, Okamoto I, Takahashi T, Nishio M, Hirata T, Kubota K, Kasahara K, Hida T, Yoshioka H, Nakanishi K, Akinaga S, Nishio K, Mitsudomi T, Nakagawa K. Phase II study of erlotinib plus tivantinib (ARQ 197) in patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer just after progression on EGFR-TKI, gefitinib or erlotinib. ESMO Open. 2016 Jul 21;1(4):e000063. doi: 10.1136/esmoopen-2016-000063. eCollection 2016.
PMID: 27843623DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 19, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 18, 2015
Record last verified: 2015-08