# 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

> **NCT05429502** · PHASE1 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 12 (actual)

## Conditions studied

- Neuroblastoma

## Interventions

- **DRUG:** Topotecan
- **DRUG:** Temozolomide
- **DRUG:** Ribociclib

## Key facts

- **NCT ID:** NCT05429502
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-12-27
- **Primary completion:** 2025-02-26
- **Final completion:** 2025-02-26
- **Target enrollment:** 12 (ACTUAL)
- **Why 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.
- **Last updated:** 2025-10-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05429502

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05429502, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05429502. Licensed CC0.

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