recurrent/refractory Ewing sarcoma, recurrent or refractory neuroblastoma
Conditions
Brief summary
Event-free survival based on investigator assessment. Tumor Specific Cohorts: - AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.03), timing, seriousness, and relationship to study therapy; laboratory test data including HbA1c as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.03), and timing; ECG parameters, and vital signs.
Detailed description
Event-free survival (EFS) assessed by an independent review committee., Objective response (OR), as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., PET-CT response after cycle 4 compared to objective response onMRI/CT., Progression free survival (PFS) based on investigator assessment., Overall survival (OS)., Adverse Events (AEs) as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) version 4.03., Pharmacokinetic parameters of palbociclib, TMZ, IRN: -Palbociclib PK: MD (assuming steady state is achieved) - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit. -TMZ PK: MD - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit. -IRN (and active metabolite, SN-38) PK: MD - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit., QoL reported by patient at baseline and after 2 and 4 cycles using ageappropriate tools., Days of hospitalization, Tumor-Specific Cohorts: -DOR, PFS, and OS. -Pharmacokinetic parameters of palbociclib,TMZ, IRN (and active metabolite, SN-38), TOPO and CTX - PK: MD - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit.
Interventions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival based on investigator assessment. Tumor Specific Cohorts: - AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.03), timing, seriousness, and relationship to study therapy; laboratory test data including HbA1c as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.03), and timing; ECG parameters, and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) assessed by an independent review committee., Objective response (OR), as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., PET-CT response after cycle 4 compared to objective response onMRI/CT., Progression free survival (PFS) based on investigator assessment., Overall survival (OS)., Adverse Events (AEs) as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) version 4.03., Pharmacokinetic parameters of palbociclib, TMZ, IRN: -Palbociclib PK: MD (assuming steady state is achieved) - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit. -TMZ PK: MD - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit. -IRN (and active metabolite, SN-38) PK: MD - Css,max, Tmax, AUCss, τ, Css,trough, and CL/F, as data permit., QoL reported by patient at baseline and after 2 and 4 cycles using ageappropriate tools., Days of hospitalization, Tumor-Specific Cohorts: -DO | — |
Countries
Czechia, France, Germany, Slovakia, Sweden
Outcome results
None listed