pediatric cancer
Conditions
Brief summary
The recommended phase II dose (RP2D) will be defined as the adult recommended dose (adjusted for weight or BSA) if toxicity and PK profiling are similar in children and in adults, or a higher dose, providing it is below or equal to the maximum tolerated dose (MTD).
Detailed description
The maximum tolerated dose (MTD) will be defined as the dose associated with or closest to 25% of DLTs in cycle 1., Dose Limiting Toxicities (DLT) will be defined using NCI CTCAE v4.03., Overall response rate (ORR) will be defined as percentage of patients achieving confirmed CR or confirmed PR as per standard methods for the underlying disease., Duration of response (DOR) will be defined as the time period between the first documented response (PR or CR) and the time of first documented progression (clinically or radiologically – Appendix 3 to 7) or death from any cause, whichever comes first. Duration of response for patients free of progression at the cut-off date will be censored at the last assessment date., Progression-free survival (PFS) will be defined as the time from treatment initiation until the date of first documented progression or death from any cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last assessment date., Overall survival (OS) will be defined as the time from treatment initiation until the date of death from any cause. Patients alive at the cut-off date will be censored at the date of last news., Adverse events according to the NCI CTCAE V4.03 in all cycles of treatment., PK parameters, including but not limited to plasma concentration time profiles, AUClast, AUCtau, Cmin, Cmax, Tmax, Clearance, Half-life time., Relationship between the molecular profile of the tumor samples, circulating tumor DNA and tumor growth.
Interventions
DRUGVotubia 2 mg dispersible tablets
DRUGINC280
DRUGFutibatinib
DRUGLEE011
DRUGgélule
DRUGRIBOCICLIB
DRUGVotubia 3 mg dispersible tablets
DRUGVINORELBINE ACCORD 30 mg
DRUGcapsule molle
DRUGPeposertib
DRUGVINORELBINE ACCORD 20 mg
DRUGCapivasertib
DRUGVotubia 5 mg dispersible tablets
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recommended phase II dose (RP2D) will be defined as the adult recommended dose (adjusted for weight or BSA) if toxicity and PK profiling are similar in children and in adults, or a higher dose, providing it is below or equal to the maximum tolerated dose (MTD). | — |
Secondary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose (MTD) will be defined as the dose associated with or closest to 25% of DLTs in cycle 1., Dose Limiting Toxicities (DLT) will be defined using NCI CTCAE v4.03., Overall response rate (ORR) will be defined as percentage of patients achieving confirmed CR or confirmed PR as per standard methods for the underlying disease., Duration of response (DOR) will be defined as the time period between the first documented response (PR or CR) and the time of first documented progression (clinically or radiologically – Appendix 3 to 7) or death from any cause, whichever comes first. Duration of response for patients free of progression at the cut-off date will be censored at the last assessment date., Progression-free survival (PFS) will be defined as the time from treatment initiation until the date of first documented progression or death from any cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last assessme | — |
Countries
Denmark, France, Italy, Netherlands, Spain
Outcome results
None listed