Who is sponsoring NCT01580735?

NCT01580735 is sponsored by Kyowa Kirin Co., Ltd..

What condition does NCT01580735 study?

NCT01580735 studies Non-small-cell Lung Cancer.

What is the status of NCT01580735?

NCT01580735 is currently COMPLETED.

Last reviewed 2015-08-16 · How we verify

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

NCT01580735 Phase 2 COMPLETED

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.

Details

Lead sponsor	Kyowa Kirin Co., Ltd.
Phase	Phase 2
Status	COMPLETED
Enrolment	40
Start date	2012-05
Completion	2015-04

Conditions

Non-small-cell Lung Cancer

Interventions

ARQ 197

Primary outcomes

Objective Response Rate — Up to 6 months
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.

Countries

Japan