Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Conditions
Brief summary
Objective Response Rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR)
Detailed description
Duration of Response (DOR), Time to Response (TTR), Clinical Benefit Rate (CBR), Intracranial tumor response in patients with measurable brain metastases, as determined by BICR using RANO or RANO-BM as applicable, CNS Progression-Free Survival (CNS-PFS) in patients with measurable CNS disease,, Progression-Free Survival (PFS), Overall Survival (OS), Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, Population PK, Ventricular repolarization, Quality-of-life and health status to examine biological markers of bone formation and resorption and markers of calcium metabolism, Assessment of bone mineral density (BMD) via dual X-ray absorptiometry (DXA) scans
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR), Time to Response (TTR), Clinical Benefit Rate (CBR), Intracranial tumor response in patients with measurable brain metastases, as determined by BICR using RANO or RANO-BM as applicable, CNS Progression-Free Survival (CNS-PFS) in patients with measurable CNS disease,, Progression-Free Survival (PFS), Overall Survival (OS), Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, Population PK, Ventricular repolarization, Quality-of-life and health status to examine biological markers of bone formation and resorption and markers of calcium metabolism, Assessment of bone mineral density (BMD) via dual X-ray absorptiometry (DXA) scans | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed