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Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03389399
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib at 90mg QD.

Condition or disease
Non-Small Cell Lung Cancer

Detailed Description:
This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Participants who enroll on this study protocol will either be taking brigatinib in the context of an ongoing clinical trial, or as part of standard of care treatment as licensed by FDA.

Study Design

Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Physiology and Systemic Inflammatory Signature Investigations in Early Onset Pulmonary Events Associated With Brigatinib Use in Non-Small Cell Lung Cancer
Anticipated Study Start Date : January 30, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Brigatinib
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days
This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Study procedures include PFTs, 6minute walk test, Modified Borg dyspnea scale (mBDS), and phlebotomy before participants commence brigatinib and on days 2 and 8 of brigatinib treatment. Participants that develop a peak reduction in DLCO of 20% or more from baseline whose DLCO does not return to their baseline level on day 8 may, at the discretion of the investigator, undergo repeated testing on a subsequent time point (e.g., day 15) for serial observation to ensure resolution of EOPE if that is the suspected cause of DLCO reduction.


Outcome Measures

Primary Outcome Measures :
  1. To estimate the incidence of Early Onset Pulmonary Events (EOPEs) [ Time Frame: 8 days ]
    EOPEs is defined as the proportion of participants with a peak reduction in Diffusion capacity in the Lung of Carbon monoxide (DLCO) of 20% or greater after commencing brigatinib at 90mg once daily QD.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective observational study. Brigatinib is not administered by this study. Instead, participants will receive brigatinib as part of an ongoing thereapeutic clinical trial or will be prescribed brigatinib, which is now an FDA-approved drug. Entry criteria for this study will focus on those suitable for this observational study. Any brigatinib-related safety procedure or follow-up will also be set forth by the FDA label or the relevant clinical trial that is administering brigatinib to the participant in this study.
Criteria

Inclusion Criteria:

  1. Provision to sign and date the consent form, indicating that he or she has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
  2. Stated willingness and ability to comply with all scheduled visits and study procedures, and be available for the duration of the study.
  3. Be a male or female aged ≥ 18.
  4. Must plan on receiving brigatinib at a starting dose of 90 mg QD, regardless of whether they are receiving brigatinib as a part of clinical trial (if they meet eligibility criteria for given clinical trial) or outside of clinical trial as part of standard of care cancer treatment per the FDA license.
  5. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC suitable for treatment with brigatinib per either FDA labels, acceptable off label use or within brigatinib clinical trials.
  6. Participants must plan on taking Brigatinib as the only systemic cancer treatment. This means that participants cannot be receiving other targeted therapies, chemotherapies, or immunotherapies while on brigatinib (Exceptions: nonimmunosuppressive supportive cancer therapies such as bone targeting agents [e.g., denosumab], and anti-emetics are allowed).
  7. Must have Hemoglobin (Hb) of ≥10 g/dL.
  8. Recovered from clinically relevant toxicities (in the opinion of the investigator) related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.03) grade ≤2.
  9. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  10. Must have clearly documented information of previously received systemic cancer treatments including chemotherapy, immunotherapy, small molecule tyrosine-kinase inhibitors (incl. ALK-targeted TKI) and stop date of most recent systemic therapy.

Exclusion Criteria:

  1. Have baseline oxygen supplementation requirement (i.e., resting O2 sats on room air ≥ 90%).
  2. Have history or presence of pulmonary interstitial disease or drug-related pneumonitis on CT imaging of chest performed within 28 days prior to starting brigatinib.
  3. Have malabsorption syndrome or other GI illness that could affect oral absorption of the study drug in the opinion of the investigator.
  4. Have had a blood transfusion within past 120 days.
  5. Have received any small molecule inhibitors, including crizotinib, within 7 days of the first dose of Brigatinib (e.g., If first scheduled dose of brigatinib is on a Monday, May 1st, 2017 then last dose of the prior line of small molecule inhibitor must have been given BEFORE Monday, April 24, 2017).
  6. Have received cytotoxic chemotherapy, investigational agents, or cytotoxic doses of radiation within 14 days of brigatinib, except SRS or stereotactic body radiosurgery to anatomic sites not involving lung tissue.
  7. Have received immunotherapy within 28 days of first dose of brigatinib.
  8. Be on corticosteroid within 48 hours prior to first dose of brigatinib.
  9. Have uncontrolled, or active cardiac, pulmonary or hematologic disease that can affect interpretation of DLCO, specifically including, but not restricted to: a. Pulmonary interstitial disease or drug-related pneumonitis b. Congestive heart failure (CHF) within 6 months prior to first dose c. Pulmonary embolism within last 6 months
  10. Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
  11. Have a known or suspected hypersensitivity to AP26113 or its excipients.
  12. Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation of the drug study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389399


Contacts
Contact: Paula Fisk 720-848-0671 PAULA.FISK@UCDENVER.EDU

Locations
United States, Colorado
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Paula Fisk         
Principal Investigator: Camidge Ross, MD         
Principal Investigator: Terry Ng         
Sponsors and Collaborators
University of Colorado, Denver
Takeda Pharmaceuticals International, Inc.
Investigators
Principal Investigator: Camidge Ross, MD University of Colorado, Denver
Principal Investigator: Terry Ng, MD University of Colorado, Denver
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03389399     History of Changes
Other Study ID Numbers: 17-0846.cc
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Brigatinib
Early Onset Pulmonary Events

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms