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

NCT01377376 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-12-07

No results posted yet for this study

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

Interventions

DRUG

ARQ 197 and Erlotinib

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

DRUG

Placebo and Erlotinib

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

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-11-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377376 on ClinicalTrials.gov