CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 75 enrolled
Drug / intervention
Larotrectinib (Vitrakvi, BAY2757556)drug
Likely dose
Not stated in 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.

Search/NCT02122913
NCT02122913Phase 1Completed
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A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

Bayer·interventional·Posted Apr 25, 2014·Updated Feb 5, 2026

In Brief

A Phase 1 clinical trial evaluating Larotrectinib (Vitrakvi, BAY2757556) for Solid Tumors Harboring NTRK Fusion. Completed, enrolled 75 participants across 8 sites.

Detailed Summary

This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors Harboring NTRK Fusion
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 25, 2014
Enrollment StartMay 4, 2014
Primary CompletionFeb 1, 2017
Study CompletionApr 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.2 years ago

Interventions

Larotrectinib (Vitrakvi, BAY2757556)drug

BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.