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Phase I/II Multicenter Study to Assess 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

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Trial Profile

Phase I/II Multicenter Study to Assess 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: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 16 Jun 2025

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At a glance

  • Drugs Ribociclib (Primary) ; Temozolomide (Primary) ; Topotecan (Primary)
  • Indications Anaplastic astrocytoma; Glioblastoma; Glioma; Medulloblastoma; Neuroblastoma; Oligodendroglioma; Rhabdoid tumour; Rhabdomyosarcoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 10 Jun 2025 Status changed from recruiting to discontinued.
  • 17 Feb 2025 Planned End Date changed from 27 Jan 2028 to 28 Jan 2028.
  • 22 Jan 2025 Planned End Date changed from 28 Feb 2029 to 27 Jan 2028.

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