This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
534
TrkA/B/C, ROS1, and ALK inhibitor
Dignity Health St Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
City of Hope Cancer Center
Duarte, California, United States
City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services
Duarte, California, United States
Scripps Clinic
La Jolla, California, United States
Objective Response Rate
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time frame: Approximately 24 months
Duration of Response
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time frame: Approximately 24 months
Time to Response
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time frame: Approximately 24 months
Clinical Benefit Rate
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time frame: Approximately 24 months
Intracranial Tumor Response
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Time frame: Approximately 24 months
CNS Progression-free Survival
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Time frame: Approximately 24 months
Progression-free Survival
Assessed by Kaplan-Meier method
Time frame: Approximately 30 months
Overall Survival
Assessed by Kaplan-Meier method
Time frame: Approximately 36 months
Population PK
Assessed by Kaplan-Meier method
Time frame: Approximately 24 months
Adverse Events
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE
Time frame: Approximately 36 months
Quality of Life
Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively
Time frame: Approximately 24 months
Bone Growth and Bone Mineral Density
Assessed with DHA scans
Time frame: Approximately 30 months
Bone Biomarkers
Measured by blood
Time frame: Approximately 30 months
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University of California San Diego Moores Cancer Center
La Jolla, California, United States
Southern California Kaiser Permanente
Los Angeles, California, United States
University of Southern California Medical Center
Los Angeles, California, United States
Univ Of California Irvine College Of Medicine
Orange, California, United States
UCSF Mount Zion Medical Ctr
San Francisco, California, United States
...and 120 more locations