logo Hematology/Oncology Research Studies: Open for Enrollment Date: 12/12/18

Category: ONCOLOGY: EARLY PHASE

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LOXO-101 (larotrectinib) in patients with tumors harboring actionable NTRK fusions

NCT#/Phase: NCT03213704
Phase 2
IRB#: 2017-095a
Description: This is a subprotocol of the MATCH trial APEC1621 and is a phase 2 trial of LOXO-101 (larotrectinib) in children with recurrent or refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses and CNS tumors) harboring NTRK gene fusion proteins. The study aims to determine the objective response rate of LOXO-101 (larotrectinib), an orally bioavailable, potent, ATP-competitive, selective inhibitor of TRKA, TRKB, and TRKC, in patients enrolled in APEC1621 who are determined to have NTRK 1, 2 or 3 translocations. LOXO-101 has shown tumor regression in non-clinical cancer models and in patients with tumors harboring NTRK gene fusion proteins.
Inclusion: Individuals who are between 12 months and 21 years of age and given a therapy assignment to MATCH to APEC1621A.
Enrollment Status: Open for enrollment
Sponsor: Children's Oncology Group
Principal Investigator(s): Carla Golden, MD
Contact(s): Christine Ho (510-428-3885 x 2609)
Diane Olzewski (510-428-3885 x 3246)
Study Link: https://clinicaltrials.gov/ct2/show/NCT03213704#

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000