Table 2.

DLT summary.

Dose level (mg/m2/dose)Number of treated patientsaNumber of evaluable patientsNumber of patients with DLTsDescription of DLTs
Ribociclib 120; everolimus 1.2550
Ribociclib 170;332Grade 3 pediatric hypertension (n = 1)
Everolimus 1.2Grade 3 ALT increased (n = 1)
Ribociclib 120; everolimus 1.21280
  • aEnrolled 22 patients, 20 patients were treated. One patient enrolled on surgical cohort deemed ineligible, and 1 patient withdrew prior to receiving investigational agents.