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Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors

NCT02706626 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).

Conditions

Interventions

DRUG

brigatinib

Single arm phase 2 trial to investigate the clinical activity in patients with advanced non-small cell lung cancer

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Takeda

    collaborator INDUSTRY

  • Vanderbilt University

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • Academic Thoracic Oncology Medical Investigators Consortium

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Stinchcombe, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2020-10-08
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02706626 on ClinicalTrials.gov