logo Hematology/Oncology Research Studies: Open for Enrollment Date: 08/07/19

Category: ONCOLOGY

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (ulixertinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations

NCT#/Phase: NCT03698994
Phase 2
IRB#: 2017-095j
Description: This is a phase 2 trial of BVD-523FB (ulixertinib) in children with relapsed or refractory solid tumors (including Non-Hodgkin lymphomas, histiocytoses and CNS tumors) harboring specified activating mutations of the MAPK pathway. BVD-523FB (ulixertinib) is a novel, reversible, ATP-competitive ERK1/2 inhibitor with high potency and ERK1/2 selectivity. BVD-523FB (ulixertinib) will be given at the dose determined by the dose escalation table (or at the established MTD/RP2D once dose escalation phase has been completed) twice daily continuously for 28-day cycles. The primary endpoint will be objective response rate as determined by RECIST. Progression free survival (PFS) will be assessed as a secondary endpoint.
Inclusion: Individuals who are between 12 months and 21 years of age and given a therapy assignment in MATCH to APEC1621J.
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/study/NCT03698994

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