Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

PHASE1

Phase

TERMINATED

Status

Enrollment

INDUSTRY

Sponsor class

Stopped Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.

Conditions

Neuroblastoma

Interventions

DRUG: Topotecan
DRUG: Temozolomide
DRUG: Ribociclib

Sponsor

Novartis Pharmaceuticals

Collaborators

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