Overview

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

Status:
Not yet recruiting

Trial end date:
2028-01-28

Target enrollment:

Participant gender:

Summary

This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Novartis Pharmaceuticals

Collaborator:

Innovative Therapies For Children with Cancer Consortium

Treatments:

Temozolomide
Topotecan