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NCT01395758 · ClinicalTrials.gov registry record · Phase 2

Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

Completed
Registry status
Phase 2
Development phase
96
Enrollment target

NCT01395758 is a Phase 2 study that has completed, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). The registered enrollment target is 96 participants.

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The verdict

NCT01395758, a Phase 2 study, has completed, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

COMPLETED
Registry status
Phase 2
Development phase
96 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

Interventions

  • DRUG ARQ 197 plus erlotinib
  • DRUG Pemetrexed, docetaxel or gemcitabine

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2011-07
Est. Completion 2016-08
Phase Phase 2

What the Registry Record Tells You About NCT01395758

The ClinicalTrials.gov registry entry for NCT01395758 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which ARQ 197 plus erlotinib is the first listed.

NCT01395758 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01395758 about?

NCT01395758 is a clinical study titled "Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer". The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

What is the current status of trial NCT01395758?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2011-07. Estimated completion is 2016-08.

What interventions are being tested in trial NCT01395758?

The interventions under investigation include: ARQ 197 plus erlotinib (DRUG), Pemetrexed, docetaxel or gemcitabine (DRUG).

Who is sponsoring clinical trial NCT01395758?

This trial is sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.