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
Study of Entrectinib in Children and Adolescents with Solid Tumors and Primary CNS Tumors
Sponsor: Ignyta, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAR2419
U.S. Govt. ID: NCT02650401
Contact: Rebecca Zylber, NP: 212-305-7212 / rjv2107@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find out more about how the study drug called entrectinib will be used in children, adolescents and young adults with treatment-resistant solid tumor in brain or body. This is a phase 1/1b study, divided into a dose escalation portion (different dose will be tested) and a dose expansion portion (one dose will be tested) in participants with relapsed (has returned) or refractory (did not respond to standard treatment) neuroblastoma or participants whose cancer was previously shown via molecular testing to have specific changes in cancer cells. Male or female subjects aged 6 months to 22 years will be enrolled, participant must have received standard of care treatment. The study will consist of four parts: Screening, Treatment, Safety Follow-Up, and Long-Term Follow-up.
This study is closed
Stergios Zacharoulis, MD
Do You Qualify?
Is your child between the ages of 6 months and 22 years of age? Yes No
Has your child been diagnosed with a solid tumor or neuroblastoma? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Rebecca Zylber, NP