Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Criterium, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the incidence of Early Onset Pulmonary Events (EOPEs) | 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. | 8 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Have baseline oxygen supplementation requirement (i.e., resting O2 sats on room air ≥ 90%).
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.
Have malabsorption syndrome or other GI illness that could affect oral absorption of the study drug in the opinion of the investigator.
Have had a blood transfusion within past 120 days.
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).
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.
Have received immunotherapy within 28 days of first dose of brigatinib.
Be on corticosteroid within 48 hours prior to first dose of brigatinib.
Have uncontrolled, or active cardiac, pulmonary or hematologic disease that can affect interpretation of DLCO, specifically including, but not restricted to:
Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
Have a known or suspected hypersensitivity to AP26113 or its excipients.
Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation of the drug study.
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Camidge Ross, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| University of Pittsburgh Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern Harold C Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G2C1 | Canada |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |