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NCT01772797 · ClinicalTrials.gov registry record · Phase 1

Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

A Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
8
Study locations

NCT01772797 is a Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 22 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT01772797, a Phase 1 study of Non-Small Cell Lung Cancer and Anaplastic Lymphoma Kinase (ALK), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
8
Study locations

Study Summary

The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.

Conditions Studied

Non-Small Cell Lung Cancer Anaplastic Lymphoma Kinase (ALK)

Interventions

  • DRUG LDK378
  • DRUG AUY922

Study Locations (8)

Colorado

  • University of Colorado Dept. of Anschutz Cancer (3) - Aurora

Massachusetts

  • Massachusetts General Hospital Mass General - Boston

Pennsylvania

  • Fox Chase Cancer Center Fox Chase Cancer (2) - Philadelphia

Utah

  • University of Utah / Huntsman Cancer Institute Huntsman - Salt Lake City

Victoria

  • Novartis Investigative Site - Melbourne

MI

  • Novartis Investigative Site - Milan

Other

  • Novartis Investigative Site - Singapore

Catalonia

  • Novartis Investigative Site - Barcelona

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2013-06
Est. Completion 2016-01
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01772797

The ClinicalTrials.gov registry entry for NCT01772797 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which LDK378 is the first listed.

NCT01772797 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Colorado, Massachusetts, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01772797 about?

NCT01772797 is a clinical study titled "Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer". The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small ce...

What is the current status of trial NCT01772797?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-06. Estimated completion is 2016-01.

What conditions does trial NCT01772797 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Anaplastic Lymphoma Kinase (ALK).

What interventions are being tested in trial NCT01772797?

The interventions under investigation include: LDK378 (DRUG), AUY922 (DRUG).

Who is sponsoring clinical trial NCT01772797?

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

Where is trial NCT01772797 being conducted?

This trial has 8 study locations across Colorado, Massachusetts, Pennsylvania, Utah, Victoria. 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.