Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- ALK Gene Amplification
- Advanced Malignant Neoplasm
- ALK Fusion Protein Expression
- ALK Gene Mutation
- Locally Advanced Malignant Solid Neoplasm
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Neoplasm in the Central Nervous System
- Metastatic Malignant Solid Neoplasm
- ROS1 Fusion Positive
- ROS1 Gene Amplification
- ROS1 Gene Mutation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 adv...
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.
Tracking Information
- NCT #
- NCT03868423
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sameek Roychowdhury, MD Ohio State University Comprehensive Cancer Center
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