Study: NCT05429502

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Topotecan
Description: Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Temozolomide
Description: Starting out dose of temozolomide for first two cohorts for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts in Phase 1-Part A will initiate at 100mg/m2/day and will be determined for Phase 1-Part B depending on safety outcome and for phase II.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: Ribociclib administered at the RP2D defined from Phase I-Part A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: Ribociclib administered at the RP2D defined from Phase I-Part A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: Ribociclib administered at the RP2D defined from Phase I-Part A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: Ribociclib administered at the RP2D defined from Phase I-Part A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib
Description: Ribociclib administered at the RP2D defined from Phase I-Part A.