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

PHASE1TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 27, 2022

Primary Completion Date

February 26, 2025

Study Completion Date

February 26, 2025

Conditions
Neuroblastoma
Interventions
DRUG

Topotecan

Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

DRUG

Temozolomide

Starting out dose of temozolomide for cohort A1 and A2 for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts, Cohort A3 and onwards, in Phase 1-Part A will initiate at 100mg/m2/day.

DRUG

Ribociclib

Starting out dose of ribociclib for cohort A1 Phase 1-Part A: 200mg/m2/day. Starting out dose for Cohort A2 and A3 was 100mg/m2/day.

Trial Locations (6)

11040

Cohen Children's Medical Center of New York, New Hyde Park

20133

Novartis Investigative Site, Milan

50937

Novartis Investigative Site, Cologne

02115

Dana Farber Cancer Institute, Boston

38105-2794

St Jude s Childrens Research Hospital, Memphis

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
collaborator

Innovative Therapies For Children with Cancer Consortium

OTHER

lead

Novartis Pharmaceuticals

INDUSTRY