At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 215 enrolled
Drug / intervention
BAY2757556 (Larotrectinib, Vitrakvi)drug
Likely dose
BAY2757556 (Larotrectinib, Vitrakvi) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion
In Brief
A Phase 2 clinical trial evaluating BAY2757556 (Larotrectinib, Vitrakvi) for Solid Tumors Harboring NTRK Fusion. Completed, enrolled 215 participants across 98 sites in 25 countries.
Detailed Summary
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors Harboring NTRK Fusion
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, India, Ireland, Italy, Japan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedOct 2015
Primary CompletionSep 2025
TodayJul 2026
First PostedOct 15, 2015
Enrollment StartSep 30, 2015
Primary CompletionSep 29, 2025
TodayJul 2, 2026
Enrollment to primary: 10.0 yearsPosted 10.7 years ago
Interventions
BAY2757556 (Larotrectinib, Vitrakvi)drug
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.