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NCT01828112 · ClinicalTrials.gov registry record · Phase 3

LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
231
Enrollment target
20
Study locations

NCT01828112 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 231 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01828112, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
231 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Conditions Studied

Interventions

  • DRUG Docetaxel
  • DRUG Pemetrexed
  • DRUG Ceritinib

Study Locations (20)

Other

  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Edegem
  • Novartis Investigative Site - Leuven
  • Novartis Investigative Site - Besançon

Florida

  • Memorial Cancer Institute - Hollywood
  • Cancer Specialists of North Florida - Jacksonville
  • University Of Miami - Miami

Texas

  • Texas Oncology-Sugarland - Sugar Land
  • Texas Oncology Cancer Care and Research Center - Waco

Arkansas

  • Highlands Oncology Group - Fayetteville

Illinois

  • Loyola University Medical Center - Marywood

Iowa

  • Uni Of Iowa Hospitals And Clinics - Iowa City

Massachusetts

  • Massachusetts General Hospital - Boston

Oklahoma

  • Oklahoma Cancer Specialists and Research Institute - Tulsa

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2013-06-28
Est. Completion 2023-11-10
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01828112

The ClinicalTrials.gov registry entry for NCT01828112 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.

NCT01828112 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT01828112 about?

NCT01828112 is a clinical study titled "LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib". The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), w...

What is the current status of trial NCT01828112?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2013-06-28. Estimated completion is 2023-11-10.

What conditions does trial NCT01828112 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT01828112?

The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), Ceritinib (DRUG).

Who is sponsoring clinical trial NCT01828112?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01828112 being conducted?

This trial has 20 study locations across Arkansas, Florida, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.