CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 33 enrolled
Drug / intervention
Larotrectinib Sulfatedrug
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/NCT03834961
NCT03834961Phase 2Active

Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Children's Oncology Group·interventional·Posted Feb 8, 2019·Updated Dec 2, 2025

In Brief

A Phase 2 clinical trial evaluating Larotrectinib Sulfate for Central Nervous System Neoplasm and 4 related conditions. Active but no longer recruiting, targeting 33 participants across 80 sites in 2 countries.

Detailed Summary

This phase II trial studies the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedFeb 8, 2019
Enrollment StartOct 25, 2019
Primary CompletionSep 30, 2024
Study CompletionJul 25, 2027
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.4 years ago

Interventions

Larotrectinib Sulfatedrug

Given PO or via NG or G tube