Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG)

Prior treatment

• All Phase 2 patients: Prior treatment with approved or investigational tyrosine receptor kinase inhibitor (TRK) or ROS1 inhibitors
• Incomplete recovery from acute effects of any surgery prior to treatment

Other illness

• Known active infections (bacterial, fungal, or viral)

Lab values

• Known congenital long QT syndrome
• History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening

Other

• Current participation in another therapeutic clinical trial

• Sex and age: male or female aged from birth to age < 18 years
• Disease status: Phase 1 portion (closed): Patients must have measurable or evaluable disease Phase 2 portion: Cohort B: Patients must have measurable or evaluable disease as defined by RANO Cohort C (closed) and D: Patients must have measurable or evaluable disease as defined per RECIST v1.1±Curie Scale Cohort D: Patients must have measurable or evaluable disease, Cohort E (closed): Patients must have measurable or evaluable disease and be assessed according to tumor type as defined per RECIST v1.1±Curie Scale or RANO
• Tumor types included below harboring NTRK1/2/3 or ROS1 gene fusions as determined locally by an appropriately validated assay performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay or the alternative, approved central laboratory for that region: Phase 1 portion: Cohort A: Relapsed or refractory extracranial solid tumors Phase 2 portion: Cohort B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions Cohort D: Extracranial solid tumors with NTRK1/2/3 or ROS1 gene fusions
• Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
• For patients enrolled via local molecular testing, an archival tumor tissue from diagnosis or, preferably, from relapsed disease is required to be submitted for independent central testing at Foundation Medicine, Inc. laboratory or the alternative, approved central assay laboratory for that region
• Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks