Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05429502
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-06-17
Brief Title:
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase III 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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide TOTEM in pediatric patients with relapsed or refractory rr neuroblastoma NB and other solid tumors including medulloblastoma MB high-grade glioma HGG malignant rhabdoid tumors MRT and rhabdomyosarcoma RMS
Detailed Description:
The study consists of Phase I -part A dose finding and Phase I - part B multiple expansion cohorts Phase II may begin after evaluation of Phase I data safety tolerability efficacy pharmacokinetics and biomarker data with consideration of other emerging data that may impact on the treatment landscape before initiating Phase II in patients with relapsed or refractory NB andor other tumors studied in Phase I
Phase I-Part A dose finding a dose finding to determine the maximum tolerated dose MTD andor recommended Phase II dose RP2D of ribociclib in combination with TOTEM
Phase I- Part B multiple expansion cohorts it will be initiated to confirm RP2D identified from Phase I-part A Multiple expansion cohorts have been planned to assess the preliminary antitumor activity and safety of ribociclib in combination with TOTEM in participants with rr NB cohort 1 MB cohort 2 HGG cohort 3 MRT cohort 4 and RMS cohort 5
Phase II- Double-blind randomized placebo controlled in rr NB It is a two-arm randomized double blinded placebo controlled parallel group trial in participants with rr NB
Phase I-Part A dose finding a dose finding to determine the maximum tolerated dose MTD andor recommended Phase II dose RP2D of ribociclib in combination with TOTEM
Phase I- Part B multiple expansion cohorts it will be initiated to confirm RP2D identified from Phase I-part A Multiple expansion cohorts have been planned to assess the preliminary antitumor activity and safety of ribociclib in combination with TOTEM in participants with rr NB cohort 1 MB cohort 2 HGG cohort 3 MRT cohort 4 and RMS cohort 5
Phase II- Double-blind randomized placebo controlled in rr NB It is a two-arm randomized double blinded placebo controlled parallel group trial in participants with rr NB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005617-14 | EUDRACT_NUMBER | None | None |