Malignant Solid Tumor - Malignant Nervous System Neoplasm Clinical Trial
Official title:
A Phase 1-2 Dose Finding, Safety and Efficacy Study of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Tumors of the Central Nervous System
Primary Objectives:
Phase 1 Part:
To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
cabazitaxel as a single agent in pediatric patients with recurrent or refractory solid
tumors including tumors of the central nervous system.
Phase 2 Part:
To determine the objective response rate (complete and partial response) and the duration of
response to cabazitaxel as a single agent in patients with recurrent or refractory high
grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).
Secondary Objectives:
Phase 1 Part:
To characterize the safety and tolerability of cabazitaxel in patients with recurrent or
refractory solid tumors including tumors of the central nervous system.
To characterize the pharmacokinetic (PK) profile of cabazitaxel in patients with recurrent
or refractory solid tumors including tumors of the central nervous system.
To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in
patients with recurrent or refractory solid tumors including tumors of the central nervous
system.
Phase 2 Part:
To characterize the safety and tolerability of cabazitaxel in patients with recurrent or
refractory HGG or DIPG.
To estimate progression free survival in patients with recurrent or refractory HGG or DIPG.
To estimate overall survival in patients with recurrent or refractory HGG or DIPG.
To characterize the plasma PK profile of cabazitaxel in patients with recurrent or
refractory HGG or DIPG.
The study duration will include a period for inclusion of up to 3 weeks and a 3-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment