Conditions: Malignant Solid Tumor - Malignant Nervous System Neoplasm
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
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 participants 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 participants 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 participants with recurrent or refractory solid tumors including tumors of the central nervous system.

To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants 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 participants 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 participants with recurrent or refractory HGG or DIPG.

To estimate progression free survival in participants with recurrent or refractory HGG or DIPG.

To estimate overall survival in participants with recurrent or refractory HGG or DIPG.

To characterize the plasma PK profile of cabazitaxel in participants with recurrent or refractory HGG or DIPG.

Detailed description:
The study duration will include a period for inclusion of up to 3 weeks and a 3-week treatment cycle(s). The participants may continue treatment until disease progression, unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up.

Arms:
arm 1: Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse event (AE) or death (from any cause). arm 2: Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 3: Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 4: Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 5: Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).

Interventions: intervention 1: Cabazitaxel (XRP6258)
Intervention descriptions: intervention 1: Pharmaceutical form: Injection Route of administration: Intravenous

Protocol document: