12
Participants
Start Date
December 27, 2022
Primary Completion Date
February 26, 2025
Study Completion Date
February 26, 2025
Topotecan
Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).
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.
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.
Cohen Children's Medical Center of New York, New Hyde Park
Novartis Investigative Site, Milan
Novartis Investigative Site, Cologne
Dana Farber Cancer Institute, Boston
St Jude s Childrens Research Hospital, Memphis
Novartis Investigative Site, Sutton
Lead Sponsor
Innovative Therapies For Children with Cancer Consortium
OTHER
Novartis Pharmaceuticals
INDUSTRY