A Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX-101) in Children and Adolescents with Recurrent or Refractory Solid Tumors and Primary CNS Tumors, with or without TRK, ROS1, or ALK Fusions

Protocol: 
AAAR2419
Phase: 
I

A Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX-101) in Children and Adolescents with Recurrent or Refractory Solid Tumors and Primary CNS Tumors, with or without TRK, ROS1, or ALK Fusions

Are you Eligible? (Inclusion Criteria)

- Male or female age ≥ 2 years and < 22 years unless enrolled in Part E
- Ability to swallow capsules unless enrolled in Part E
- Patient's cancer must have relapsed after or failed to respond to frontline
curative therapy or there must not be other potentially curative treatment
options available.
Tumor type:
Part A: Relapsed or refractory extracranial solid tumors
Part B: Relapsed or refractory primary brain tumors with NTRK1/2/3, ROS1, or ALK
molecular alterations.
Part C: Relapsed or refractory neuroblastoma
Part D: Relapsed or refractory non-neuroblastoma, extracranial solid tumors with
NTRK1/2/3, ROS1, or ALK gene fusions

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States