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About
This phase II trial studies how well brigatinib works in treating patients with ALK and ROS1 gene alterations and solid cancers that have spread to nearby tissue and lymph nodes or other places in the body. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Full description
PRIMARY OBJECTIVES:
I. To evaluate the overall response rate (ORR) of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK (excluding lung) and ROS1 (all solid tumors).
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK (excluding lung) and ROS1 (all solid tumors).
II. To assess progression free survival (PFS) and overall survival (OS) in patients with advanced ALK or ROS1 mutated solid tumors treated with brigatinib.
III. To assess sensitivity and durability of response to brigatinib in different solid tumor types.
IV. To assess the role of intertumoral and intratumoral heterogeneity in the development of resistance to brigatinib.
V. To identify candidate genomic (including circulating tumor deoxyribonucleic acid [DNA]) and proteomic biomarkers of tumor sensitivity and resistance to brigatinib using high-throughput approaches (exome, transcriptome, reverse phase protein array [RPPA]).
TERTIARY OBJECTIVES:
I. Correlation of brigatinib exposure with efficacy and safety. II. Correlation of tumor and plasma biomarkers with brigatinib efficacy and safety.
OUTLINE:
Patients receive brigatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 52 weeks.
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Inclusion criteria
Exclusion criteria
Patients with hematological malignancies
Patients with ALK positive (+) lung cancer
Major surgery (e.g. thoracic, abdominal, vascular, neurosurgery) within 30 days prior to registration on study
Pregnant women or mothers who are breastfeeding
Patients who are incarcerated
Patients who have a history or the presence at baseline of pulmonary interstitial disease or drug-related pneumonitis, or radiation pneumonitis
Patients who have a known history of human immunodeficiency virus (HIV); testing not required in the absence of history
Patients with history of clinically significant bleeding disorder or history of active significant gastrointestinal (GI) bleeding within 3 months of first dose of brigatinib
Patients who have malabsorption syndrome or other GI illness or condition that could affect oral absorption of the study drug
History of allergic or suspected hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to brigatinib
Patients with history of clinically significant atrial arrhythmias (requiring any anti-arrhythmic therapy or as determined by the treating physician) or any history of ventricular arrhythmias
Patients who have significant, uncontrolled or active cardiovascular disease, including but not restricted to the following:
Clinically significant, uncontrolled intercurrent illness including, but not limited to:
Patients on medications known to be associated with torsades de pointes
Patients who have uncontrolled hypertension; patients with hypertension should be under treatment on study entry to control blood pressure
Patients who have received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery
Patients who have received monoclonal antibodies or had major surgery within 30 days of the first dose of brigatinib
Patients who have not recovered (=< Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from adverse events (with the exception of alopecia) due to agents administered more than 4 weeks earlier
Patients with symptomatic CNS metastases that are neurologically unstable or require increasing dose of corticosteroids
Patients with current spinal cord compression
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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